Trial Outcomes & Findings for Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia (NCT NCT00257192)

Last Updated: 2021-03-25

Results Overview

BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

284 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2021-03-25

Participant Flow

A planned interim analysis resulted in recommendation from Data Safety Monitoring Board (DSMB) to terminate study due to futility per the interim analysis charter (p-value = 0.9840). Only one active subject in the study was affected by this decision.

Screening visit followed by a 1 to 10 day period to allow for wash-out of exclusionary medications.

Participant milestones

Participant milestones
Measure	Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Overall Study STARTED	193	91
Overall Study Received Study Treatment	193	90
Overall Study COMPLETED	135	52
Overall Study NOT COMPLETED	58	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Overall Study Adverse Event	21	10
Overall Study Laboratory abnormality	1	1
Overall Study Lost to Follow-up	3	3
Overall Study Insufficient clinical response	18	18
Overall Study Withdrawal by Subject	14	2
Overall Study Randomized but not treated	0	1
Overall Study Study terminated by sponsor	1	0
Overall Study Miscellaneous	0	4

Baseline Characteristics

Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ziprasidone n=193 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=90 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Total n=283 Participants Total of all reporting groups
Age, Customized >12 years and <13 years at start of treatment	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Age, Customized Between 13 and 17 years	189 participants n=5 Participants	90 participants n=7 Participants	279 participants n=5 Participants
Age, Continuous	15.3 years STANDARD_DEVIATION 1.4 • n=5 Participants	15.4 years STANDARD_DEVIATION 1.4 • n=7 Participants	15.3 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	28 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	62 Participants n=7 Participants	171 Participants n=5 Participants
Ethnicity Hispanic / Latino	21 participants n=5 Participants	9 participants n=7 Participants	30 participants n=5 Participants
Ethnicity Not Hispanic / Latino	172 participants n=5 Participants	81 participants n=7 Participants	253 participants n=5 Participants
Race White	116 particpants n=5 Participants	60 particpants n=7 Participants	176 particpants n=5 Participants
Race Black	17 particpants n=5 Participants	2 particpants n=7 Participants	19 particpants n=5 Participants
Race Asian	38 particpants n=5 Participants	17 particpants n=7 Participants	55 particpants n=5 Participants
Race Hispanic	9 particpants n=5 Participants	3 particpants n=7 Participants	12 particpants n=5 Participants
Race Other	13 particpants n=5 Participants	8 particpants n=7 Participants	21 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Breast (females) Stage 1	0 particpants n=5 Participants	1 particpants n=7 Participants	1 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Breast (females) Stage 2	6 particpants n=5 Participants	3 particpants n=7 Participants	9 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Breast (females) Stage 3	16 particpants n=5 Participants	4 particpants n=7 Participants	20 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Breast (females) Stage 4	35 particpants n=5 Participants	11 particpants n=7 Participants	46 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Breast (females) Stage 5	25 particpants n=5 Participants	9 particpants n=7 Participants	34 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Breast (females) Not applicable	109 particpants n=5 Participants	62 particpants n=7 Participants	171 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Breast (females) Missing (not answered)	2 particpants n=5 Participants	0 particpants n=7 Participants	2 particpants n=5 Participants
Tanner adolescent pubertal self-assessment: Genitalia (males) Stage 1	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Genitalia (males) Stage 2	9 participants n=5 Participants	3 participants n=7 Participants	12 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Genitalia (males) Stage 3	25 participants n=5 Participants	16 participants n=7 Participants	41 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Genitalia (males) Stage 4	57 participants n=5 Participants	26 participants n=7 Participants	83 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Genitalia (males) Stage 5	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Genitalia (males) Not applicable	82 participants n=5 Participants	28 participants n=7 Participants	110 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Genitalia (males) Missing (not answered)	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Pubic hair (females and males) Stage 1	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Pubic hair (females and males) Stage 2	13 participants n=5 Participants	7 participants n=7 Participants	20 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Pubic hair (females and males) Stage 3	36 participants n=5 Participants	13 participants n=7 Participants	49 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Pubic hair (females and males) Stage 4	90 participants n=5 Participants	43 participants n=7 Participants	133 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Pubic hair (females and males) Stage 5	52 participants n=5 Participants	24 participants n=7 Participants	76 participants n=5 Participants
Tanner adolescent pubertal self-assessment: Pubic hair (females and males) Missing (not answered)	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Height	164.9 centimeters (cm) STANDARD_DEVIATION 10.1 • n=5 Participants	167.8 centimeters (cm) STANDARD_DEVIATION 10.0 • n=7 Participants	165.8 centimeters (cm) STANDARD_DEVIATION 10.1 • n=5 Participants
Weight	61.2 kilograms (kg) STANDARD_DEVIATION 15.5 • n=5 Participants	64.3 kilograms (kg) STANDARD_DEVIATION 15.7 • n=7 Participants	62.2 kilograms (kg) STANDARD_DEVIATION 15.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.

Outcome measures

Outcome measures
Measure	Ziprasidone n=189 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=87 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6	-14.16 scores on a scale Standard Error 0.78	-12.35 scores on a scale Standard Error 1.05

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT; N=number of subjects with analyzable data at post-baseline observation.

CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.

Outcome measures

Outcome measures
Measure	Ziprasidone n=190 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=87 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6	-1.05 scores on a scale Standard Error 0.08	-0.84 scores on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT; N=number of subjects with analyzable data at post-baseline observation.

PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.

Outcome measures

Outcome measures
Measure	Ziprasidone n=183 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=86 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6	-23.58 scores on a scale Standard Error 1.42	-21.01 scores on a scale Standard Error 1.73

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT; N=number of subjects with analyzable data at post-baseline observation.

Outcome measures

Outcome measures
Measure	Ziprasidone n=183 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=86 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6 Positive score	-7.22 scores on a scale Standard Error 0.44	-5.88 scores on a scale Standard Error 0.56
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6 Negative score	-5.51 scores on a scale Standard Error 0.43	-5.09 scores on a scale Standard Error 0.51

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT; N=number of subjects with analyzable data at post-baseline observation.

CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.

Outcome measures

Outcome measures
Measure	Ziprasidone n=190 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=87 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Clinical Global Impression of Improvement (CGI-I) Score at Week 6	2.66 scores on a scale Standard Error 0.09	2.85 scores on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Early termination (ET)

Population: ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward \[LOCF\] imputation used for Week 6 LOCF timepoint.

CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.

Outcome measures

Outcome measures
Measure	Ziprasidone n=193 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=90 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Children's Global Assessment Scale (CGAS) Week 2 (n=183, 86)	4.7 scores on a scale Standard Deviation 8.7 • Interval 3.4 to 5.9	2.6 scores on a scale Standard Deviation 5.8 • Interval 1.3 to 3.8
Change From Baseline in Children's Global Assessment Scale (CGAS) Week 4 (n=155, 63)	7.9 scores on a scale Standard Deviation 10.4 • Interval 6.2 to 9.5	6.2 scores on a scale Standard Deviation 8.9 • Interval 4.0 to 8.5
Change From Baseline in Children's Global Assessment Scale (CGAS) Week 6 (n=135, 52)	10.9 scores on a scale Standard Deviation 11.8 • Interval 8.9 to 12.9	10.8 scores on a scale Standard Deviation 9.9 • Interval 8.0 to 13.5
Change From Baseline in Children's Global Assessment Scale (CGAS) ET (n=20, 15)	1.3 scores on a scale Standard Deviation 10.1 • Interval -3.4 to 6.0	1.7 scores on a scale Standard Deviation 8.9 • Interval -3.2 to 6.6
Change From Baseline in Children's Global Assessment Scale (CGAS) Week 6 [LOCF] (n=185, 87)	8.4 scores on a scale Standard Deviation 11.8 • Interval 6.7 to 10.2	6.4 scores on a scale Standard Deviation 10.6 • Interval 4.2 to 8.7

SECONDARY outcome

Timeframe: Baseline, Week 6, ET

Population: ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.

CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.

Outcome measures

Outcome measures
Measure	Ziprasidone n=193 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=90 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Child Health Questionnaire (CHQ) Family cohesion: Week 6	1.9 scores on a scale Standard Deviation 21.3 • Interval -1.7 to 5.6	-0.8 scores on a scale Standard Deviation 19.7 • Interval -6.4 to 4.8
Change From Baseline in Child Health Questionnaire (CHQ) Self-esteem: Week 6	6.0 scores on a scale Standard Deviation 17.5 • Interval 3.1 to 9.0	9.0 scores on a scale Standard Deviation 22.9 • Interval 2.5 to 15.5
Change From Baseline in Child Health Questionnaire (CHQ) Family cohesion: ET	-1.8 scores on a scale Standard Deviation 18.4 • Interval -8.0 to 4.4	-2.6 scores on a scale Standard Deviation 16.1 • Interval -8.5 to 3.3
Change From Baseline in Child Health Questionnaire (CHQ) Emotion, behavior: Week 6	16.2 scores on a scale Standard Deviation 29.8 • Interval 11.0 to 21.3	13.8 scores on a scale Standard Deviation 31.1 • Interval 4.9 to 22.6
Change From Baseline in Child Health Questionnaire (CHQ) Self-esteem: ET	1.0 scores on a scale Standard Deviation 20.6 • Interval -5.9 to 8.0	1.3 scores on a scale Standard Deviation 14.0 • Interval -3.8 to 6.5
Change From Baseline in Child Health Questionnaire (CHQ) Self-esteem: Week 6 [LOCF]	5.0 scores on a scale Standard Deviation 18.2 • Interval 2.3 to 7.7	6.4 scores on a scale Standard Deviation 20.2 • Interval 1.9 to 10.9
Change From Baseline in Child Health Questionnaire (CHQ) Family cohesion: Week 6 [LOCF]	1.2 scores on a scale Standard Deviation 20.8 • Interval -2.0 to 4.3	-1.1 scores on a scale Standard Deviation 18.1 • Interval -5.2 to 2.9
Change From Baseline in Child Health Questionnaire (CHQ) Physical health: Week 6	3.5 scores on a scale Standard Deviation 33.9 • Interval -2.3 to 9.3	5.0 scores on a scale Standard Deviation 28.0 • Interval -3.0 to 13.0
Change From Baseline in Child Health Questionnaire (CHQ) Physical health: ET	-6.5 scores on a scale Standard Deviation 32.9 • Interval -17.6 to 4.7	3.2 scores on a scale Standard Deviation 23.3 • Interval -5.3 to 11.8
Change From Baseline in Child Health Questionnaire (CHQ) Global health: Week 6 [LOCF]	2.8 scores on a scale Standard Deviation 19.9 • Interval -0.1 to 5.8	1.4 scores on a scale Standard Deviation 23.7 • Interval -3.9 to 6.6
Change From Baseline in Child Health Questionnaire (CHQ) Global behavior: Week 6	9.4 scores on a scale Standard Deviation 23.6 • Interval 5.4 to 13.4	10.9 scores on a scale Standard Deviation 22.1 • Interval 4.6 to 17.2
Change From Baseline in Child Health Questionnaire (CHQ) Global behavior: ET	6.4 scores on a scale Standard Deviation 21.4 • Interval -0.8 to 13.6	-0.5 scores on a scale Standard Deviation 23.0 • Interval -8.8 to 7.8
Change From Baseline in Child Health Questionnaire (CHQ) Bodily pain: ET	4.7 scores on a scale Standard Deviation 23.0 • Interval -3.1 to 12.5	0.0 scores on a scale Standard Deviation 14.6 • Interval -5.3 to 5.3
Change From Baseline in Child Health Questionnaire (CHQ) Time impact on parent: ET	2.0 scores on a scale Standard Deviation 25.8 • Interval -6.7 to 10.7	1.8 scores on a scale Standard Deviation 21.7 • Interval -6.2 to 9.7
Change From Baseline in Child Health Questionnaire (CHQ) Time impact on parent: Week 6 [LOCF]	7.4 scores on a scale Standard Deviation 25.5 • Interval 3.6 to 11.2	8.0 scores on a scale Standard Deviation 23.1 • Interval 2.9 to 13.2
Change From Baseline in Child Health Questionnaire (CHQ) Emotional impact on parent: Week 6	8.9 scores on a scale Standard Deviation 21.6 • Interval 5.2 to 12.5	10.0 scores on a scale Standard Deviation 22.3 • Interval 3.7 to 16.3
Change From Baseline in Child Health Questionnaire (CHQ) Physical function: Week 6 [LOCF]	3.3 scores on a scale Standard Deviation 20.8 • Interval 0.2 to 6.4	3.7 scores on a scale Standard Deviation 22.8 • Interval -1.3 to 8.7
Change From Baseline in Child Health Questionnaire (CHQ) General health perception: Week 6	1.1 scores on a scale Standard Deviation 11.6 • Interval -0.9 to 3.1	3.3 scores on a scale Standard Deviation 11.7 • Interval 0.0 to 6.7
Change From Baseline in Child Health Questionnaire (CHQ) General health perception: Week 6 [LOCF]	0.4 scores on a scale Standard Deviation 11.8 • Interval -1.3 to 2.2	1.8 scores on a scale Standard Deviation 11.5 • Interval -0.8 to 4.3
Change From Baseline in Child Health Questionnaire (CHQ) Change in health: Week 6	0.5 scores on a scale Standard Deviation 1.1 • Interval 0.3 to 0.6	0.6 scores on a scale Standard Deviation 1.0 • Interval 0.3 to 0.9
Change From Baseline in Child Health Questionnaire (CHQ) Psychosocial health global subscale: Week 6 [LOCF]	5.9 scores on a scale Standard Deviation 9.8 • Interval 4.4 to 7.4	4.8 scores on a scale Standard Deviation 10.0 • Interval 2.6 to 7.1
Change From Baseline in Child Health Questionnaire (CHQ) Physical health: Week 6 [LOCF]	1.4 scores on a scale Standard Deviation 33.8 • Interval -3.8 to 6.5	4.8 scores on a scale Standard Deviation 26.0 • Interval -1.0 to 10.6
Change From Baseline in Child Health Questionnaire (CHQ) Bodily pain: Week 6	4.4 scores on a scale Standard Deviation 21.6 • Interval 0.7 to 8.1	8.0 scores on a scale Standard Deviation 19.4 • Interval 2.5 to 13.5
Change From Baseline in Child Health Questionnaire (CHQ) Bodily pain: Week 6 [LOCF]	4.5 scores on a scale Standard Deviation 21.9 • Interval 1.2 to 7.8	4.9 scores on a scale Standard Deviation 18.1 • Interval 0.9 to 8.9
Change From Baseline in Child Health Questionnaire (CHQ) Global health: Week 6	5.0 scores on a scale Standard Deviation 18.2 • Interval 2.0 to 8.1	8.5 scores on a scale Standard Deviation 24.7 • Interval 1.5 to 15.5
Change From Baseline in Child Health Questionnaire (CHQ) Global health: ET	-5.4 scores on a scale Standard Deviation 24.0 • Interval -13.5 to 2.7	-9.1 scores on a scale Standard Deviation 17.4 • Interval -15.3 to -2.8
Change From Baseline in Child Health Questionnaire (CHQ) Global behavior: Week 6 [LOCF]	8.8 scores on a scale Standard Deviation 23.1 • Interval 5.3 to 12.3	6.5 scores on a scale Standard Deviation 23.1 • Interval 1.4 to 11.7
Change From Baseline in Child Health Questionnaire (CHQ) Emotion, behavior: ET	4.0 scores on a scale Standard Deviation 43.1 • Interval -10.6 to 18.6	-2.5 scores on a scale Standard Deviation 22.7 • Interval -10.8 to 5.8
Change From Baseline in Child Health Questionnaire (CHQ) Emotion, behavior: Week 6 [LOCF]	13.6 scores on a scale Standard Deviation 33.4 • Interval 8.5 to 18.6	7.8 scores on a scale Standard Deviation 29.2 • Interval 1.3 to 14.3
Change From Baseline in Child Health Questionnaire (CHQ) Time impact on parent: Week 6	8.8 scores on a scale Standard Deviation 25.4 • Interval 4.5 to 13.1	11.8 scores on a scale Standard Deviation 23.1 • Interval 5.2 to 18.4
Change From Baseline in Child Health Questionnaire (CHQ) Emotional impact on parent: ET	3.5 scores on a scale Standard Deviation 21.2 • Interval -3.7 to 10.6	2.7 scores on a scale Standard Deviation 12.6 • Interval -1.8 to 7.3
Change From Baseline in Child Health Questionnaire (CHQ) Emotional impact on parent: Week 6 [LOCF]	7.7 scores on a scale Standard Deviation 21.6 • Interval 4.5 to 11.0	7.4 scores on a scale Standard Deviation 19.4 • Interval 3.1 to 11.6
Change From Baseline in Child Health Questionnaire (CHQ) Mental health: Week 6	8.1 scores on a scale Standard Deviation 15.3 • Interval 5.5 to 10.7	12.6 scores on a scale Standard Deviation 18.2 • Interval 7.4 to 17.8
Change From Baseline in Child Health Questionnaire (CHQ) Mental health: ET	1.3 scores on a scale Standard Deviation 17.9 • Interval -4.8 to 7.3	-0.8 scores on a scale Standard Deviation 12.0 • Interval -5.2 to 3.6
Change From Baseline in Child Health Questionnaire (CHQ) Mental health: Week 6 [LOCF]	6.7 scores on a scale Standard Deviation 16.1 • Interval 4.2 to 9.1	7.5 scores on a scale Standard Deviation 17.4 • Interval 3.6 to 11.4
Change From Baseline in Child Health Questionnaire (CHQ) Physical function: Week 6	5.6 scores on a scale Standard Deviation 19.7 • Interval 2.2 to 8.9	5.9 scores on a scale Standard Deviation 25.2 • Interval -1.3 to 13.1
Change From Baseline in Child Health Questionnaire (CHQ) Physical function: ET	-5.4 scores on a scale Standard Deviation 22.5 • Interval -13.0 to 2.2	-0.2 scores on a scale Standard Deviation 17.7 • Interval -6.6 to 6.2
Change From Baseline in Child Health Questionnaire (CHQ) General health perception: ET	-2.2 scores on a scale Standard Deviation 12.3 • Interval -6.3 to 2.0	-0.6 scores on a scale Standard Deviation 10.8 • Interval -4.5 to 3.3
Change From Baseline in Child Health Questionnaire (CHQ) Family activities: Week 6 [LOCF]	7.5 scores on a scale Standard Deviation 21.7 • Interval 4.3 to 10.8	7.8 scores on a scale Standard Deviation 22.0 • Interval 2.9 to 12.7
Change From Baseline in Child Health Questionnaire (CHQ) Change in health: ET	-0.4 scores on a scale Standard Deviation 1.0 • Interval -0.7 to -0.1	-0.1 scores on a scale Standard Deviation 0.8 • Interval -0.4 to 0.2
Change From Baseline in Child Health Questionnaire (CHQ) Behavior scale: Week 6	9.0 scores on a scale Standard Deviation 17.1 • Interval 6.1 to 11.9	9.0 scores on a scale Standard Deviation 16.8 • Interval 4.2 to 13.8
Change From Baseline in Child Health Questionnaire (CHQ) Behavior scale: ET	7.6 scores on a scale Standard Deviation 15.2 • Interval 2.4 to 12.9	0.6 scores on a scale Standard Deviation 17.1 • Interval -5.6 to 6.7
Change From Baseline in Child Health Questionnaire (CHQ) Behavior scale: Week 6 [LOCF]	8.7 scores on a scale Standard Deviation 16.7 • Interval 6.2 to 11.3	5.8 scores on a scale Standard Deviation 17.4 • Interval 1.9 to 9.6
Change From Baseline in Child Health Questionnaire (CHQ) Change in health: Week 6 [LOCF]	0.3 scores on a scale Standard Deviation 1.1 • Interval 0.1 to 0.5	0.3 scores on a scale Standard Deviation 1.0 • Interval 0.1 to 0.6
Change From Baseline in Child Health Questionnaire (CHQ) Physical health global subscale: Week 6	1.8 scores on a scale Standard Deviation 9.7 • Interval 0.2 to 3.5	2.4 scores on a scale Standard Deviation 9.8 • Interval -0.4 to 5.2
Change From Baseline in Child Health Questionnaire (CHQ) Physical health global subscale: ET	-2.8 scores on a scale Standard Deviation 11.8 • Interval -6.9 to 1.3	0.1 scores on a scale Standard Deviation 4.4 • Interval -1.5 to 1.7
Change From Baseline in Child Health Questionnaire (CHQ) Physical health global subscale: Week 6 [LOCF]	0.9 scores on a scale Standard Deviation 10.3 • Interval -0.7 to 2.4	1.6 scores on a scale Standard Deviation 8.2 • Interval -0.2 to 3.4
Change From Baseline in Child Health Questionnaire (CHQ) Psychosocial health global subscale: Week 6	6.6 scores on a scale Standard Deviation 9.5 • Interval 5.0 to 8.3	7.7 scores on a scale Standard Deviation 11.0 • Interval 4.5 to 10.9
Change From Baseline in Child Health Questionnaire (CHQ) Psychosocial health global subscale: ET	3.1 scores on a scale Standard Deviation 10.4 • Interval -0.5 to 6.6	0.0 scores on a scale Standard Deviation 5.7 • Interval -2.0 to 2.1
Change From Baseline in Child Health Questionnaire (CHQ) Family activities: Week 6	9.2 scores on a scale Standard Deviation 22.6 • Interval 5.3 to 13.0	14.6 scores on a scale Standard Deviation 22.5 • Interval 8.2 to 21.0
Change From Baseline in Child Health Questionnaire (CHQ) Family activities: ET	1.3 scores on a scale Standard Deviation 16.8 • Interval -4.5 to 7.1	-4.6 scores on a scale Standard Deviation 16.5 • Interval -10.6 to 1.5

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 6

CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.

Outcome measures

Outcome measures
Measure	Ziprasidone n=173 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=74 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score Week 1 (n=165, 69)	-2.4 scores on a scale Standard Deviation 7.1 • Interval -3.53 to -1.33	-1.3 scores on a scale Standard Deviation 5.8 • Interval -2.72 to 0.05
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score Week 2 (n=161, 71)	-2.5 scores on a scale Standard Deviation 8.0 • Interval -3.79 to -1.29	-1.0 scores on a scale Standard Deviation 6.2 • Interval -2.42 to 0.51
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score Week 3 (n=146, 64)	-3.0 scores on a scale Standard Deviation 6.7 • Interval -4.06 to -1.88	-0.7 scores on a scale Standard Deviation 5.7 • Interval -2.08 to 0.77
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score Week 6 [LOCF] (n=167, 71)	-2.3 scores on a scale Standard Deviation 8.2 • Interval -3.58 to -1.07	-0.3 scores on a scale Standard Deviation 8.8 • Interval -2.37 to 1.81
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score Week 4 (n=138, 51)	-2.7 scores on a scale Standard Deviation 7.4 • Interval -3.96 to -1.46	-1.0 scores on a scale Standard Deviation 6.5 • Interval -2.79 to 0.87
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score Week 5 (n=126, 44)	-3.1 scores on a scale Standard Deviation 7.0 • Interval -4.32 to -1.86	-0.8 scores on a scale Standard Deviation 8.3 • Interval -3.32 to 1.73
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score Week 6 (n=119, 42)	-3.0 scores on a scale Standard Deviation 7.4 • Interval -4.3 to -1.62	-1.9 scores on a scale Standard Deviation 6.7 • Interval -3.94 to 0.22

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 6

CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.

Outcome measures

Outcome measures
Measure	Ziprasidone n=180 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=84 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score Week 1 (n=179, 82)	-2.8 scores on a scale Standard Deviation 6.6 • Interval -3.78 to -1.84	-1.4 scores on a scale Standard Deviation 5.7 • Interval -2.62 to -0.11
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score Week 2 (n=174, 80)	-4.2 scores on a scale Standard Deviation 7.3 • Interval -5.24 to -3.07	-2.5 scores on a scale Standard Deviation 5.6 • Interval -3.73 to -1.25
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score Week 3 (n=157, 69)	-5.5 scores on a scale Standard Deviation 7.4 • Interval -6.69 to -4.35	-3.2 scores on a scale Standard Deviation 5.4 • Interval -4.48 to -1.9
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score Week 4 (n=148, 59)	-6.0 scores on a scale Standard Deviation 7.6 • Interval -7.2 to -4.74	-4.9 scores on a scale Standard Deviation 6.6 • Interval -6.65 to -3.18
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score Week 5 (n=135, 49)	-7.0 scores on a scale Standard Deviation 8.5 • Interval -8.47 to -5.57	-5.6 scores on a scale Standard Deviation 5.9 • Interval -7.3 to -3.92
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score Week 6 (n=126, 47)	-7.9 scores on a scale Standard Deviation 7.9 • Interval -9.29 to -6.52	-6.5 scores on a scale Standard Deviation 5.5 • Interval -8.13 to -4.89
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score Week 6 [LOCF] (n=178, 82)	-5.8 scores on a scale Standard Deviation 8.7 • Interval -7.07 to -4.51	-4.0 scores on a scale Standard Deviation 7.3 • Interval -5.64 to -2.43

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 6

CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).

Outcome measures

Outcome measures
Measure	Ziprasidone n=192 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=90 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 Week 6 [LOCF] (n=189, 87)	0.0 scores on a scale Standard Deviation 0.6	-0.0 scores on a scale Standard Deviation 0.5
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 Week 1 (n=188, 86)	-0.1 scores on a scale Standard Deviation 0.4	-0.0 scores on a scale Standard Deviation 0.5
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 Week 2 (n=182, 86)	-0.0 scores on a scale Standard Deviation 0.5	-0.1 scores on a scale Standard Deviation 0.5
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 Week 3 (n=165, 74)	-0.1 scores on a scale Standard Deviation 0.5	-0.1 scores on a scale Standard Deviation 0.3
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 Week 4 (n=154, 63)	0.0 scores on a scale Standard Deviation 0.5	-0.1 scores on a scale Standard Deviation 0.5
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 Week 5 (n=141, 54)	0.0 scores on a scale Standard Deviation 0.4	-0.1 scores on a scale Standard Deviation 0.5
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 Week 6 (n=134, 52)	-0.0 scores on a scale Standard Deviation 0.3	-0.1 scores on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6

Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).

Outcome measures

Outcome measures
Measure	Ziprasidone n=40 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=15 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1 Week 2 (n=38, 15)	-0.3 scores on a scale Standard Deviation 0.9	-0.2 scores on a scale Standard Deviation 0.7
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1 Week 6 (n=30, 8)	-0.6 scores on a scale Standard Deviation 1.1	-0.1 scores on a scale Standard Deviation 1.4
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1 Week 6 [LOCF] (n=39, 15)	-0.6 scores on a scale Standard Deviation 1.0	-0.1 scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, Week 6, ET

Population: ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).

A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).

Outcome measures

Outcome measures
Measure	Ziprasidone n=174 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=83 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Sustained Attention: Week 6 [LOCF] (n=143, 68)	1.7 scores on a scale Standard Deviation 12.4 • Interval -0.54 to 3.47	-0.9 scores on a scale Standard Deviation 12.6 • Interval -3.98 to 2.1
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Sedation: Week 6 (n=124, 47)	0.0 scores on a scale Standard Deviation 1.7 • Interval -0.27 to 0.33	-0.4 scores on a scale Standard Deviation 1.8 • Interval -0.98 to 0.08
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Sedation: ET (n=23, 26)	0.0 scores on a scale Standard Deviation 2.3 • Interval -0.98 to 0.98	0.2 scores on a scale Standard Deviation 1.3 • Interval -0.34 to 0.73
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Sedation: Week 6 [LOCF] (n=147, 72)	0.0 scores on a scale Standard Deviation 1.8 • Interval -0.28 to 0.3	-0.2 scores on a scale Standard Deviation 1.7 • Interval -0.63 to 0.16
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Verbal Memory: Week 6 (n=124, 47)	1.3 scores on a scale Standard Deviation 12.1 • Interval -0.83 to 3.45	0.5 scores on a scale Standard Deviation 14.0 • Interval -3.63 to 4.59
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Verbal Memory: ET (n=24, 25)	-2.3 scores on a scale Standard Deviation 13.9 • Interval -8.22 to 3.53	-2.6 scores on a scale Standard Deviation 15.1 • Interval -8.8 to 3.66
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Verbal Memory: Week 6 [LOCF] (n=148, 71)	0.7 scores on a scale Standard Deviation 12.4 • Interval -1.39 to 2.66	-0.5 scores on a scale Standard Deviation 14.4 • Interval -3.95 to 2.87
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Visual Memory: Week 6 (n=124, 46)	0.5 scores on a scale Standard Deviation 13.3 • Interval -1.89 to 2.83	2.0 scores on a scale Standard Deviation 14.5 • Interval -2.31 to 6.28
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Visual Memory: ET (n=24, 26)	-3.8 scores on a scale Standard Deviation 10.2 • Interval -8.1 to 0.48	0.4 scores on a scale Standard Deviation 14.2 • Interval -5.28 to 6.17
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Visual Memory: Week 6 [LOCF] (n=148, 71)	-0.2 scores on a scale Standard Deviation 12.9 • Interval -2.46 to 1.69	1.2 scores on a scale Standard Deviation 14.3 • Interval -2.19 to 4.6
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Processing Speed: Week 6 (n=124, 46)	1.3 scores on a scale Standard Deviation 13.5 • Interval -1.06 to 3.73	1.0 scores on a scale Standard Deviation 12.0 • Interval -2.58 to 4.53
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Processing Speed: ET (n=24, 25)	-10.6 scores on a scale Standard Deviation 34.5 • Interval -25.14 to 3.99	0.5 scores on a scale Standard Deviation 5.4 • Interval -1.73 to 2.74
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Processing Speed: Week 6 [LOCF] (n=148, 70)	-0.6 scores on a scale Standard Deviation 18.9 • Interval -3.73 to 2.45	0.6 scores on a scale Standard Deviation 10.1 • Interval -1.76 to 3.06
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Reasoning: Week 6 (n=122, 46)	2.2 scores on a scale Standard Deviation 12.0 • Interval 0.09 to 4.41	-0.7 scores on a scale Standard Deviation 14.6 • Interval -5.03 to 3.65
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Reasoning: ET (n=23, 25)	1.3 scores on a scale Standard Deviation 15.8 • Interval -5.56 to 8.12	3.3 scores on a scale Standard Deviation 14.0 • Interval -2.47 to 9.13
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Reasoning: Week 6 [LOCF] (n=145, 70)	1.9 scores on a scale Standard Deviation 12.7 • Interval -0.16 to 4.03	0.7 scores on a scale Standard Deviation 14.1 • Interval -2.66 to 4.06
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Executive Functioning: Week 6 (n=123, 46)	2.9 scores on a scale Standard Deviation 15.4 • Interval 0.19 to 5.68	2.7 scores on a scale Standard Deviation 18.2 • Interval -2.76 to 8.07
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Sustained Attention: Week 6 (n=120, 45)	2.0 scores on a scale Standard Deviation 12.3 • Interval -0.18 to 4.26	-1.6 scores on a scale Standard Deviation 13.1 • Interval -5.59 to 2.3
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Sustained Attention: ET (n=23, 24)	0.5 scores on a scale Standard Deviation 13.5 • Interval -5.27 to 6.37	1.5 scores on a scale Standard Deviation 11.6 • Interval -3.42 to 6.37
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Executive Functioning: ET (n=23, 26)	-6.7 scores on a scale Standard Deviation 9.1 • Interval -10.61 to -2.77	4.6 scores on a scale Standard Deviation 13.2 • Interval -0.68 to 9.95
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Executive Functioning: Week 6 [LOCF] (n=146, 71)	1.4 scores on a scale Standard Deviation 14.9 • Interval -1.04 to 3.88	3.2 scores on a scale Standard Deviation 16.6 • Interval -0.71 to 7.14
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Working Memory: Week 6 (n=120, 45)	1.9 scores on a scale Standard Deviation 12.9 • Interval -0.4 to 4.26	0.5 scores on a scale Standard Deviation 12.9 • Interval -3.32 to 4.41
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Working Memory: ET (n=23, 24)	3.2 scores on a scale Standard Deviation 13.5 • Interval -2.66 to 9.03	3.7 scores on a scale Standard Deviation 11.0 • Interval -0.93 to 8.39
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales Working Memory: Week 6 [LOCF] (n=143, 68)	2.0 scores on a scale Standard Deviation 12.9 • Interval -0.2 to 4.1	1.3 scores on a scale Standard Deviation 12.2 • Interval -1.64 to 4.27

SECONDARY outcome

Timeframe: Baseline, Week 6, ET

Outcome measures

Outcome measures
Measure	Ziprasidone n=168 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=79 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index Neurocognitive Index: Week 6 (n=120, 45)	1.8 scores on a scale Standard Deviation 7.1	0.8 scores on a scale Standard Deviation 7.5
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index Neurocognitive Index: Week 6 [LOCF] (n=143, 67)	1.0 scores on a scale Standard Deviation 7.4	1.1 scores on a scale Standard Deviation 7.4
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index Neurocognitive Index: ET (n=23, 23)	-2.7 scores on a scale Standard Deviation 7.6	2.2 scores on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 6

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.

Outcome measures

Outcome measures
Measure	Ziprasidone n=189 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=87 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) Week 4 (n=154, 62)	0.4 scores on a scale Standard Deviation 2.6 • Interval -0.01 to 0.83	-0.0 scores on a scale Standard Deviation 0.6 • Interval -0.2 to 0.11
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) Week 1 (n=189, 85)	0.5 scores on a scale Standard Deviation 2.8 • Interval 0.12 to 0.93	0.1 scores on a scale Standard Deviation 0.9 • Interval -0.1 to 0.29
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) Week 2 (n=182, 85)	0.5 scores on a scale Standard Deviation 2.4 • Interval 0.17 to 0.88	-0.0 scores on a scale Standard Deviation 0.5 • Interval -0.13 to 0.08
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) Week 3 (n=165, 74)	0.7 scores on a scale Standard Deviation 3.1 • Interval 0.18 to 1.15	0.3 scores on a scale Standard Deviation 1.6 • Interval -0.09 to 0.65
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) Week 5 (n=141, 54)	0.2 scores on a scale Standard Deviation 2.4 • Interval -0.18 to 0.63	-0.0 scores on a scale Standard Deviation 1.0 • Interval -0.3 to 0.26
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) Week 6 (n=134, 52)	0.2 scores on a scale Standard Deviation 2.5 • Interval -0.27 to 0.58	-0.2 scores on a scale Standard Deviation 0.8 • Interval -0.37 to 0.06
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) Week 6 [LOCF] (n=189, 86)	0.3 scores on a scale Standard Deviation 2.5 • Interval -0.09 to 0.63	-0.1 scores on a scale Standard Deviation 0.6 • Interval -0.21 to 0.07

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 6

BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.

Outcome measures

Outcome measures
Measure	Ziprasidone n=190 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=88 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item Week 4 (n=155, 63)	0.1 scores on a scale Standard Deviation 0.6 • Interval -0.03 to 0.15	-0.0 scores on a scale Standard Deviation 0.2 • Interval -0.08 to 0.01
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item Week 1 (n=190, 86)	0.1 scores on a scale Standard Deviation 0.6 • Interval -0.03 to 0.15	0.1 scores on a scale Standard Deviation 0.4 • Interval 0.01 to 0.2
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item Week 6 (n=135, 52)	0.0 scores on a scale Standard Deviation 0.5 • Interval -0.06 to 0.11	0.0 scores on a scale Standard Deviation 0.2 • Interval -0.06 to 0.06
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item Week 6 [LOCF] (n=190, 87)	0.0 scores on a scale Standard Deviation 0.6 • Interval -0.08 to 0.08	0.0 scores on a scale Standard Deviation 0.2 • Interval -0.04 to 0.06
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item Week 5 (n=142, 54)	0.1 scores on a scale Standard Deviation 0.5 • Interval -0.03 to 0.15	0.0 scores on a scale Standard Deviation 0.2 • Interval -0.05 to 0.05
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item Week 2 (n=183, 86)	0.1 scores on a scale Standard Deviation 0.7 • Interval 0.02 to 0.22	0.0 scores on a scale Standard Deviation 0.3 • Interval -0.05 to 0.07
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item Week 3 (n=166, 74)	0.1 scores on a scale Standard Deviation 0.6 • Interval -0.04 to 0.15	0.0 scores on a scale Standard Deviation 0.3 • Interval -0.02 to 0.1

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 6

AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.

Outcome measures

Outcome measures
Measure	Ziprasidone n=190 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=88 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score Week 1 (n=190, 86)	0.2 scores on a scale Standard Deviation 1.6 • Interval -0.04 to 0.42	-0.0 scores on a scale Standard Deviation 0.4 • Interval -0.1 to 0.06
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score Week 2 (n=183, 86)	0.1 scores on a scale Standard Deviation 1.6 • Interval -0.09 to 0.37	0.0 scores on a scale Standard Deviation 0.6 • Interval -0.1 to 0.17
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score Week 3 (n=166, 74)	0.1 scores on a scale Standard Deviation 1.3 • Interval -0.12 to 0.28	0.1 scores on a scale Standard Deviation 1.0 • Interval -0.08 to 0.37
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score Week 4 (n=155, 63)	0.1 scores on a scale Standard Deviation 0.8 • Interval -0.07 to 0.18	-0.0 scores on a scale Standard Deviation 0.8 • Interval -0.23 to 0.17
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score Week 5 (n=142, 54)	-0.1 scores on a scale Standard Deviation 0.7 • Interval -0.18 to 0.05	0.0 scores on a scale Standard Deviation 0.4 • Interval -0.12 to 0.12
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score Week 6 (n=135, 52)	0.0 scores on a scale Standard Deviation 0.6 • Interval -0.11 to 0.11	0.0 scores on a scale Standard Deviation 0.5 • Interval -0.15 to 0.15
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score Week 6 [LOCF] (n=190, 87)	0.0 scores on a scale Standard Deviation 0.8 • Interval -0.11 to 0.11	-0.0 scores on a scale Standard Deviation 0.7 • Interval -0.18 to 0.14

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6, ET

Population: ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.

Outcome measures

Outcome measures
Measure	Ziprasidone n=189 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=87 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Number of Subjects Per Response on the School Placement Questionnaire: School Situation ET: Not enrolled or mental illness (n=32, 25)	10 participants	3 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation ET: Not enrolled or other (n=32, 25)	4 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6 [LOCF]: Enrolled or attend (n=183, 86)	47 participants	23 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6 [LOCF]: Not attend or mental illness	50 participants	86 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 2: Enrolled or vacation (n=179, 84)	20 participants	11 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 2: Not enrolled or mental illness (n=179, 84)	36 participants	15 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 2: Not enrolled or other (n=179, 84)	23 participants	12 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6: Enrolled or attend (n=134, 51)	38 participants	18 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6: Not attend or mental illness (n=134, 51)	36 participants	7 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6: Not attend or other (n=134, 51)	3 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6: Enrolled or vacation (n=134, 51)	14 participants	5 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6: Not enrolled or mental illness (n=134, 51)	23 participants	11 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6: Not enrolled or other (n=134, 51)	20 participants	10 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation ET: Enrolled or vacation (n=32, 25)	5 participants	4 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6 [LOCF]: Not attend or other (n=183, 86)	3 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6 [LOCF]: Enrolled or vacation (n=183, 86)	21 participants	10 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6 [LOCF]: Not enrolled or mental illness	36 participants	17 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 6 [LOCF]: Not enrolled or other (n=183, 86)	26 participants	12 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation ET: Not attend or mental illness (n=32, 25)	8 participants	14 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation ET: Not attend or other (n=32, 25)	0 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Baseline: Enrolled or attend (n=185, 85)	40 participants	15 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Baseline: Not attend or mental illness (n=185, 85)	62 participants	26 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Baseline: Not attend or other (n=185, 85)	2 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Baseline: Enrolled or vacation (n=185, 85)	20 participants	19 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Baseline: Not enrolled or mental illness	36 participants	12 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Baseline: Not enrolled or other (n=185, 85)	25 participants	13 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 2: Enrolled or attend (n=179, 84)	38 participants	20 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 2: Not attend or mental illness (n=179, 84)	59 participants	24 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation Week 2: Not attend or other (n=179, 84)	3 participants	2 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Situation ET: Enrolled or attend (n=32, 25)	5 participants	3 participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6, ET

Outcome measures

Outcome measures
Measure	Ziprasidone n=189 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=87 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 2: Frequent absences (n=82, 36)	11 participants	4 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 2: Did not attend (n=82, 36)	25 participants	8 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6: No absences (n=67, 24)	16 participants	8 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6: Only a few absences (n=67, 24)	22 participants	12 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance ET: Only a few absences (n=12, 12)	4 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance ET: Not applicable or vacation (n=12, 12)	1 participants	3 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6 [LOCF]: Only a few absences (n=89, 37)	26 participants	13 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Baseline: No absences (n=88, 42)	20 participants	7 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Baseline: Only a few absences (n=88, 42)	16 participants	15 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Baseline: Frequent absences (n=88, 42)	13 participants	2 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Baseline: Did not attend (n=88, 42)	26 participants	7 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Baseline: Not applicable or vacation (n=88, 42)	13 participants	11 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 2: No absences (n=82, 36)	19 participants	8 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 2: Only a few absences (n=82, 36)	14 participants	9 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 2: Not applicable or vacation (n=82, 36)	13 participants	7 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6: Frequent absences (n=67, 24)	5 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6: Did not attend (n=67, 24)	13 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6: Not applicable or vacation (n=67, 24)	11 participants	4 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance ET: No absences (n=12, 12)	1 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance ET: Frequent absences (n=12, 12)	2 participants	5 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance ET: Did not attend (n=12, 12)	4 participants	4 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6 [LOCF]: No absences (n=89, 37)	18 participants	8 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6 [LOCF]: Frequent absences (n=89, 37)	11 participants	4 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6 [LOCF]: Did not attend (n=89, 37)	21 participants	4 participants
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance Week 6[LOCF]: Not applicable or vacation(n=89,37)	13 participants	8 participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6, ET

Outcome measures

Outcome measures
Measure	Ziprasidone n=189 Participants Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=87 Participants Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 2: Excellent (n=60, 26)	5 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 2: Good (n=60, 26)	12 participants	8 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 2: Poor (n=60, 26)	17 participants	5 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6: Excellent (n=52, 21)	4 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6: Fair (n=52, 21)	17 participants	11 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance ET: Excellent (n=8, 7)	0 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance ET: Good (n=8, 7)	0 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance ET: Fair (n=8, 7)	5 participants	3 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance ET: Poor (n=8, 7)	2 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance ET: Very poor (n=8, 7)	1 participants	2 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Baseline: Excellent (n=64, 29)	4 participants	2 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Baseline: Good (n=64, 29)	10 participants	6 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Baseline: Fair (n=64, 29)	25 participants	14 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Baseline: Poor (n=64, 29)	19 participants	3 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Baseline: Very poor (n=64, 29)	6 participants	4 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 2: Fair (n=60, 26)	20 participants	10 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 2: Very poor (n=60, 26)	6 participants	2 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6: Good (n=52, 21)	16 participants	8 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6: Poor (n=52, 21)	12 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6: Very poor (n=52, 21)	3 participants	0 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6 [LOCF]: Excellent (n=68, 28)	4 participants	1 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6 [LOCF]: Good (n=68, 28)	18 participants	9 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6 [LOCF]: Fair (n=68, 28)	24 participants	14 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6 [LOCF]: Poor (n=68, 28)	16 participants	2 participants
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance Week 6 [LOCF]: Very poor (n=68, 28)	6 participants	2 participants

Adverse Events

Ziprasidone

Serious events: 9 serious events

Other events: 110 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ziprasidone n=193 participants at risk Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=90 participants at risk Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Injury, poisoning and procedural complications Overdose	0.52% 1/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications Skin laceration	0.52% 1/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Aggression	0.00% 0/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	1.1% 1/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Anxiety	0.52% 1/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Depression	0.52% 1/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Hallucination, auditory	0.52% 1/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Hostility	0.52% 1/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Impulsive behaviour	0.52% 1/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Psychotic disorder	0.00% 0/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	1.1% 1/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Schizophrenia	1.0% 2/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Suicidal ideation	1.0% 2/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	0.00% 0/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.

Other adverse events

Other adverse events
Measure	Ziprasidone n=193 participants at risk Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.	Placebo n=90 participants at risk Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \< 45 kg) for duration of the study.
Gastrointestinal disorders Nausea	9.8% 19/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	2.2% 2/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders Vomiting	6.2% 12/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	3.3% 3/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders Fatigue	8.8% 17/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	4.4% 4/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications Overdose	5.7% 11/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	4.4% 4/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Akathisia	6.7% 13/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	3.3% 3/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Dizziness	9.3% 18/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	1.1% 1/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Extrapyramidal disorder	11.4% 22/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	1.1% 1/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Headache	7.8% 15/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	2.2% 2/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Somnolence	19.7% 38/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	6.7% 6/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Tremor	7.8% 15/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	1.1% 1/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders Insomnia	9.3% 18/193 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.	14.4% 13/90 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment. Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.

Additional Information

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