Trial Outcomes & Findings for Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (NCT NCT03768726)

Last Updated: 2021-06-16

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

23 participants

Primary outcome timeframe

A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)

Results posted on

2021-06-16

Participant Flow

Participants who participated in study A1281198 (NCT02075047) and consented for treatment with open label ziprasidone were enrolled in the current study A1281201 (NCT03768726).

Participant milestones

Participant milestones
Measure	Ziprasidone in A1281198 and A1281201 Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight greater than or equal to (\>=) 45 kilogram (kg) had a target total daily dose range of 120-160 milligram per day (mg/day) given in 2 divided doses with food. Participants with body weight less than (\<) 45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Treatment Phase STARTED	10	13
Treatment Phase COMPLETED	2	10
Treatment Phase NOT COMPLETED	8	3
Follow-Up STARTED	8	12
Follow-Up Received Treatment	8	12
Follow-Up COMPLETED	2	9
Follow-Up NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ziprasidone in A1281198 and A1281201 Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight greater than or equal to (\>=) 45 kilogram (kg) had a target total daily dose range of 120-160 milligram per day (mg/day) given in 2 divided doses with food. Participants with body weight less than (\<) 45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Treatment Phase Adverse Event	2	2
Treatment Phase Lost to Follow-up	1	0
Treatment Phase Withdrawal By Parent/Guardian	2	0
Treatment Phase Withdrawal by Subject	3	1
Follow-Up Adverse Event	2	2
Follow-Up Withdrawal By Parent/Guardian	1	1
Follow-Up Withdrawal by Subject	2	0
Follow-Up Other	1	0

Baseline Characteristics

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.	Total n=23 Participants Total of all reporting groups
Age, Continuous	14.0 years STANDARD_DEVIATION 2.3 • n=5 Participants	14.2 years STANDARD_DEVIATION 2.0 • n=7 Participants	14.1 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)

Population: The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	7 Participants	12 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	1 Participants

SECONDARY outcome

Timeframe: A1281201: Day 1 up to 1 Week after last dose of study medication (maximum up to 27 Weeks)

Population: The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.

Hemoglobin (Hg), hematocrit, erythrocytes: \<0.8\*lower limits of normal (LLN); platelets: \<0.5\*LLN\>1.75\*upper limits of normal (ULN); leukocytes (leu), glucose-fasting:\<0.6\*LLN\>1.5\*ULN; lymphocytes (lym), lym/leu, neutrophils (neu), neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: \<0.8\*LLN\>1.2\*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: \>1.2\*ULN; bilirubin (total, direct, indirect):\>1.5\*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol (total, LDL, HDL), triglycerides, Hg A1C: \>1.3\*ULN; sodium: \<0.95\*LLN\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLLN\>1.1\*ULN; prolactin: \>1.1\*ULN; creatine kinase: \>2.0\*ULN; urobilinogen: \>=1; Urine-specific gravity: \<1.003\>1.030, pH: \<4.5 \>8, glucose, protein, bilirubin, nitrite, leukocyte esterase, ketones: \>=1.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=8 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Number of Participants With Laboratory Abnormalities	5 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), Week 26 of A1281201

Population: The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.

Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia (if medically indicated), extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Number of Participants With Physical Examination Abnormalities at Baseline and Week 26 Baseline	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities at Baseline and Week 26 Week 26	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Population: The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study. Here 'number analyzed' signifies number of participants evaluable for each specified row.

Change from baseline in sitting and standing systolic and diastolic blood pressure in millimeter of mercury (mmHg) was reported.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 14	-0.80 mmHg Standard Deviation 9.039	-4.55 mmHg Standard Deviation 6.933
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 18	-2.67 mmHg Standard Deviation 8.327	-1.73 mmHg Standard Deviation 13.342
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Baseline	111.70 mmHg Standard Deviation 13.712	111.38 mmHg Standard Deviation 11.384
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 1	2.44 mmHg Standard Deviation 10.944	-1.00 mmHg Standard Deviation 11.505
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 2	0.43 mmHg Standard Deviation 6.024	0.08 mmHg Standard Deviation 10.431
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 4	3.29 mmHg Standard Deviation 8.036	-1.83 mmHg Standard Deviation 8.321
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 6	3.17 mmHg Standard Deviation 6.969	-3.45 mmHg Standard Deviation 11.903
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 10	-0.80 mmHg Standard Deviation 9.203	-3.09 mmHg Standard Deviation 11.674
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 14	-2.80 mmHg Standard Deviation 9.011	-7.09 mmHg Standard Deviation 8.949
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 18	-2.67 mmHg Standard Deviation 8.327	-0.82 mmHg Standard Deviation 10.852
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 22	-5.00 mmHg Standard Deviation 1.414	1.40 mmHg Standard Deviation 11.568
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Week 26	-0.63 mmHg Standard Deviation 9.620	-2.23 mmHg Standard Deviation 14.219
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Systolic Blood Pressure, Change at Follow up Visit	0.75 mmHg Standard Deviation 7.365	7.67 mmHg Standard Deviation 4.041
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Baseline	113.40 mmHg Standard Deviation 10.690	111.38 mmHg Standard Deviation 12.738
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 1	-0.67 mmHg Standard Deviation 11.916	-1.00 mmHg Standard Deviation 8.161
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 2	2.86 mmHg Standard Deviation 13.753	1.33 mmHg Standard Deviation 12.759
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 4	-1.57 mmHg Standard Deviation 7.138	2.17 mmHg Standard Deviation 11.707
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 6	1.67 mmHg Standard Deviation 7.230	-2.00 mmHg Standard Deviation 14.457
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 10	-0.60 mmHg Standard Deviation 9.423	-2.18 mmHg Standard Deviation 11.391
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 22	-7.00 mmHg Standard Deviation 7.071	5.40 mmHg Standard Deviation 13.006
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Week 26	-3.38 mmHg Standard Deviation 7.230	-5.33 mmHg Standard Deviation 12.010
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Systolic Blood Pressure, Change at Follow up Visit	-5.50 mmHg Standard Deviation 8.544	2.50 mmHg Standard Deviation 4.950
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Baseline	71.00 mmHg Standard Deviation 7.688	72.00 mmHg Standard Deviation 9.256
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 1	0.67 mmHg Standard Deviation 10.794	-1.67 mmHg Standard Deviation 9.633
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 2	-4.14 mmHg Standard Deviation 3.185	0.17 mmHg Standard Deviation 8.376
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 4	0.14 mmHg Standard Deviation 6.768	-2.17 mmHg Standard Deviation 10.744
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 6	-0.83 mmHg Standard Deviation 8.183	1.00 mmHg Standard Deviation 13.176
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 10	-3.40 mmHg Standard Deviation 4.393	-7.09 mmHg Standard Deviation 10.387
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 14	-6.20 mmHg Standard Deviation 6.058	-3.91 mmHg Standard Deviation 10.094
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 18	-2.67 mmHg Standard Deviation 3.786	0.27 mmHg Standard Deviation 15.186
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 22	-5.50 mmHg Standard Deviation 2.121	-1.30 mmHg Standard Deviation 9.019
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Week 26	-2.50 mmHg Standard Deviation 6.302	-2.46 mmHg Standard Deviation 10.548
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting Diastolic Blood Pressure, Change at Follow up Visit	-1.75 mmHg Standard Deviation 13.175	-1.67 mmHg Standard Deviation 8.145
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Baseline	73.90 mmHg Standard Deviation 6.402	74.85 mmHg Standard Deviation 4.930
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 1	-1.00 mmHg Standard Deviation 7.483	-4.45 mmHg Standard Deviation 6.654
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 2	-4.14 mmHg Standard Deviation 3.132	-0.33 mmHg Standard Deviation 4.924
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 4	-3.14 mmHg Standard Deviation 7.625	-2.67 mmHg Standard Deviation 10.465
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 6	-1.17 mmHg Standard Deviation 5.776	-2.82 mmHg Standard Deviation 7.910
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 10	0.40 mmHg Standard Deviation 5.941	-4.36 mmHg Standard Deviation 7.215
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 14	-3.00 mmHg Standard Deviation 3.317	-4.09 mmHg Standard Deviation 7.516
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 18	-5.33 mmHg Standard Deviation 3.055	-0.91 mmHg Standard Deviation 12.136
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 22	0.00 mmHg Standard Deviation 5.657	-4.30 mmHg Standard Deviation 10.646
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Week 26	-0.50 mmHg Standard Deviation 4.408	-4.33 mmHg Standard Deviation 8.700
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing Diastolic Blood Pressure, Change at Follow-up Visit	-7.75 mmHg Standard Deviation 10.905	-3.00 mmHg Standard Deviation 2.828

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline pulse rate in beats per minute was reported in sitting and standing positions.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Baseline	77.90 beats per minute Standard Deviation 9.678	73.38 beats per minute Standard Deviation 11.701
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 1	0.78 beats per minute Standard Deviation 8.969	2.00 beats per minute Standard Deviation 9.254
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 2	0.00 beats per minute Standard Deviation 6.758	8.08 beats per minute Standard Deviation 11.782
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 4	-3.29 beats per minute Standard Deviation 7.365	2.00 beats per minute Standard Deviation 9.789
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 6	-1.17 beats per minute Standard Deviation 7.139	2.00 beats per minute Standard Deviation 10.954
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 10	3.40 beats per minute Standard Deviation 11.261	0.18 beats per minute Standard Deviation 14.098
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 14	-3.00 beats per minute Standard Deviation 14.799	-0.91 beats per minute Standard Deviation 13.308
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 18	-0.33 beats per minute Standard Deviation 8.622	1.09 beats per minute Standard Deviation 10.606
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 22	-12.00 beats per minute Standard Deviation 8.485	4.30 beats per minute Standard Deviation 12.056
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Week 26	-2.50 beats per minute Standard Deviation 11.452	-2.69 beats per minute Standard Deviation 8.5787
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Sitting, Change at Follow-up Visit	-2.50 beats per minute Standard Deviation 9.469	2.67 beats per minute Standard Deviation 12.858
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Baseline	80.00 beats per minute Standard Deviation 11.303	83.08 beats per minute Standard Deviation 13.554
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 1	2.75 beats per minute Standard Deviation 9.270	1.09 beats per minute Standard Deviation 11.709
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 2	5.33 beats per minute Standard Deviation 7.528	7.18 beats per minute Standard Deviation 12.131
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 4	2.67 beats per minute Standard Deviation 10.270	1.27 beats per minute Standard Deviation 17.641
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 6	-3.00 beats per minute Standard Deviation 6.000	0.70 beats per minute Standard Deviation 13.857
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 10	6.00 beats per minute Standard Deviation 10.066	-0.20 beats per minute Standard Deviation 12.017
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 14	-2.20 beats per minute Standard Deviation 13.236	-6.00 beats per minute Standard Deviation 10.914
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 18	-2.00 beats per minute Standard Deviation 6.928	2.30 beats per minute Standard Deviation 13.639
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 22	-10.00 beats per minute Standard Deviation 2.828	2.50 beats per minute Standard Deviation 12.095
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Week 26	2.86 beats per minute Standard Deviation 14.381	-0.33 beats per minute Standard Deviation 10.680
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Standing, Change at Follow-up Visit	-3.33 beats per minute Standard Deviation 4.619	-1.00 beats per minute Standard Deviation 21.213

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in height and waist circumference in centimeter (cm) was reported.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Height, Baseline	159.82 cm Standard Deviation 10.182	161.69 cm Standard Deviation 11.996
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Height, Change at Week 6	0.27 cm Standard Deviation 0.455	0.77 cm Standard Deviation 0.984
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Height, Change at Week 26	2.04 cm Standard Deviation 1.938	0.55 cm Standard Deviation 1.535
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Height, Change at Follow-up Visit	0.90 cm Standard Deviation 1.562	2.42 cm Standard Deviation 1.413
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Waist Circumference, Baseline	78.89 cm Standard Deviation 11.278	80.23 cm Standard Deviation 13.981
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Waist Circumference, Change at Week 6	-0.94 cm Standard Deviation 2.483	2.23 cm Standard Deviation 7.527
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Waist Circumference, Change at Week 26	-1.02 cm Standard Deviation 2.278	1.29 cm Standard Deviation 4.210
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Waist Circumference, Change at Follow-up Visit	-6.40 cm Standard Deviation 13.777	2.01 cm Standard Deviation 3.778

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in body weight in kilogram (kg) was reported.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit Change at Follow-up Visit	1.47 kg Standard Deviation 1.629	4.68 kg Standard Deviation 2.639
Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit Change at Week 6	0.82 kg Standard Deviation 1.343	0.78 kg Standard Deviation 2.530
Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit Change at Week 26	1.62 kg Standard Deviation 2.528	2.33 kg Standard Deviation 4.431
Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit Baseline	57.76 kg Standard Deviation 17.634	62.40 kg Standard Deviation 19.375

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in BMI in kilogram per meter square (kg/m\^2) was reported.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit Baseline	22.31 kg/m^2 Standard Deviation 5.081	23.37 kg/m^2 Standard Deviation 4.709
Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit Change at Week 6	0.38 kg/m^2 Standard Deviation 0.519	0.91 kg/m^2 Standard Deviation 2.234
Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit Change at Week 26	0.19 kg/m^2 Standard Deviation 0.954	0.78 kg/m^2 Standard Deviation 1.800
Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit Change at Follow-up Visit	0.35 kg/m^2 Standard Deviation 0.589	1.54 kg/m^2 Standard Deviation 1.447

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

BMI z-score was reported using the Children's Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit Baseline	0.58 z-score Standard Deviation 1.187	1.06 z-score Standard Deviation 0.852
Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit Change at Week 6	0.12 z-score Standard Deviation 0.122	-0.02 z-score Standard Deviation 0.511
Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit Change at Week 26	0.21 z-score Standard Deviation 0.747	0.11 z-score Standard Deviation 0.506
Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit Change at Follow-up Visit	0.01 z-score Standard Deviation 0.207	0.26 z-score Standard Deviation 0.330

SECONDARY outcome

Timeframe: Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in heart rate in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Baseline	77.8 beats per minute Standard Deviation 9.19	71.5 beats per minute Standard Deviation 14.12
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Week 4	-7.3 beats per minute Standard Deviation 8.08	0.4 beats per minute Standard Deviation 13.20
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Week 6	-5.0 beats per minute Standard Deviation 13.04	-3.9 beats per minute Standard Deviation 14.49
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Week 14	-0.6 beats per minute Standard Deviation 15.22	-2.6 beats per minute Standard Deviation 15.23
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Week 22	-5.0 beats per minute Standard Deviation 0.00	0.3 beats per minute Standard Deviation 16.99
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Follow-up Visit	-15.0 beats per minute	-13.0 beats per minute
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Day 1	-4.0 beats per minute Standard Deviation 9.40	-1.2 beats per minute Standard Deviation 9.09
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Week 1	-2.0 beats per minute Standard Deviation 19.24	0.4 beats per minute Standard Deviation 16.12
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Week 2	7.4 beats per minute Standard Deviation 16.69	5.0 beats per minute Standard Deviation 16.28
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Change at Week 26	-7.8 beats per minute Standard Deviation 12.33	-3.0 beats per minute Standard Deviation 8.69

SECONDARY outcome

Change from baseline in PR interval, QT interval corrected using the Bazett's correction (QTcB), QT interval corrected using the Fridericia's formula (QTcF), QT interval, RR interval, QRS duration in millisecond (msec) was reported.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Baseline	145.3 msec Standard Deviation 14.77	148.5 msec Standard Deviation 14.47
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Week 14	-6.8 msec Standard Deviation 4.87	-2.0 msec Standard Deviation 9.42
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Week 2	6.4 msec Standard Deviation 17.58	11.4 msec Standard Deviation 24.01
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Week 4	-7.4 msec Standard Deviation 9.36	2.9 msec Standard Deviation 18.81
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Week 6	9.0 msec Standard Deviation 23.04	0.2 msec Standard Deviation 27.75
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Week 14	-5.0 msec Standard Deviation 21.30	3.9 msec Standard Deviation 24.20
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Week 14	-3.4 msec Standard Deviation 20.70	10.6 msec Standard Deviation 21.47
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Week 22	69.0 msec Standard Deviation 12.73	-13.7 msec Standard Deviation 208.06
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Week 22	1.0 msec Standard Deviation 2.83	-0.3 msec Standard Deviation 6.60
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Week 26	3.5 msec Standard Deviation 4.54	3.5 msec Standard Deviation 4.93
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Follow-up Visit	-4.0 msec	11.0 msec
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Day 1	1.0 msec Standard Deviation 9.07	0.4 msec Standard Deviation 10.25
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Week 1	3.6 msec Standard Deviation 14.17	-2.6 msec Standard Deviation 9.17
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Week 2	-4.6 msec Standard Deviation 9.22	2.3 msec Standard Deviation 11.69
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Week 4	3.0 msec Standard Deviation 5.16	1.1 msec Standard Deviation 10.17
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Week 6	0.0 msec Standard Deviation 12.60	4.0 msec Standard Deviation 10.89
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Week 22	12.5 msec Standard Deviation 17.68	1.7 msec Standard Deviation 9.25
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Week 26	-0.3 msec Standard Deviation 7.76	-0.9 msec Standard Deviation 12.70
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit PR interval, Change at Follow-up Visit	-3.0 msec	17.0 msec
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Baseline	415.8 msec Standard Deviation 16.13	412.4 msec Standard Deviation 18.87
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Day 1	1.0 msec Standard Deviation 13.31	2.2 msec Standard Deviation 15.72
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Week 1	1.2 msec Standard Deviation 18.34	15.6 msec Standard Deviation 21.74
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Week 22	19.0 msec Standard Deviation 8.49	8.9 msec Standard Deviation 30.94
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Week 26	3.0 msec Standard Deviation 26.88	2.5 msec Standard Deviation 21.43
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcB interval, Change at Follow-up Visit	-14.0 msec	-5.0 msec
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Baseline	398.5 msec Standard Deviation 14.80	401.8 msec Standard Deviation 18.57
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Day 1	3.8 msec Standard Deviation 13.36	2.3 msec Standard Deviation 11.40
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Week 1	3.0 msec Standard Deviation 12.65	14.0 msec Standard Deviation 13.74
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Week 2	-0.3 msec Standard Deviation 15.30	5.8 msec Standard Deviation 13.98
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Week 4	-1.3 msec Standard Deviation 13.90	1.3 msec Standard Deviation 12.87
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Week 6	12.5 msec Standard Deviation 17.21	3.2 msec Standard Deviation 18.94
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Week 14	-4.6 msec Standard Deviation 10.01	6.2 msec Standard Deviation 12.62
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Week 22	23.5 msec Standard Deviation 7.78	7.0 msec Standard Deviation 21.21
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Week 26	10.6 msec Standard Deviation 16.77	4.3 msec Standard Deviation 17.51
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QTcF interval, Change at Follow-up Visit	0.0 msec	6.0 msec
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Baseline	366.3 msec Standard Deviation 21.79	382.8 msec Standard Deviation 35.86
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Day 1	9.6 msec Standard Deviation 22.88	2.2 msec Standard Deviation 17.17
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Week 1	7.8 msec Standard Deviation 37.06	10.8 msec Standard Deviation 29.55
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Week 2	-11.4 msec Standard Deviation 32.93	-4.1 msec Standard Deviation 26.25
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Week 4	10.4 msec Standard Deviation 25.34	-2.1 msec Standard Deviation 25.98
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Week 6	20.5 msec Standard Deviation 26.71	9.0 msec Standard Deviation 25.65
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Week 22	34.0 msec Standard Deviation 5.66	4.1 msec Standard Deviation 31.27
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Week 26	24.5 msec Standard Deviation 18.90	7.2 msec Standard Deviation 20.99
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QT interval, Change at Follow-up Visit	23.0 msec	26.0 msec
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Baseline	781.0 msec Standard Deviation 95.07	873.6 msec Standard Deviation 171.26
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Day 1	33.6 msec Standard Deviation 100.49	-5.7 msec Standard Deviation 102.47
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Week 1	30.7 msec Standard Deviation 203.15	-17.7 msec Standard Deviation 187.46
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Week 2	-73.3 msec Standard Deviation 161.14	-61.2 msec Standard Deviation 179.08
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval , Change at Week 4	70.1 msec Standard Deviation 86.24	-26.9 msec Standard Deviation 159.35
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Week 6	56.5 msec Standard Deviation 152.31	40.6 msec Standard Deviation 173.34
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Week 14	3.6 msec Standard Deviation 157.07	33.2 msec Standard Deviation 169.68
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Week 26	99.1 msec Standard Deviation 165.02	20.4 msec Standard Deviation 111.79
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit RR interval, Change at Follow-up Visit	134.0 msec	134.0 msec
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Baseline	84.4 msec Standard Deviation 7.23	85.8 msec Standard Deviation 5.90
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Day 1	2.1 msec Standard Deviation 3.76	2.8 msec Standard Deviation 3.41
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Week 1	1.0 msec Standard Deviation 3.54	3.8 msec Standard Deviation 5.64
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Week 2	0.1 msec Standard Deviation 3.24	1.7 msec Standard Deviation 6.31
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Week 4	2.0 msec Standard Deviation 4.16	1.5 msec Standard Deviation 5.25
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Week 6	-0.8 msec Standard Deviation 3.06	2.5 msec Standard Deviation 5.05
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit QRS duration, Change at Week 14	-1.2 msec Standard Deviation 4.15	2.9 msec Standard Deviation 7.30

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total score is sum of individual item scores, ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected. Rows with only non-zero data/values for change in SARS total score at specified time points, for at least 1 reporting arm, are reported below.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Baseline	0.4 units on a scale Standard Deviation 1.26	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 1	-0.2 units on a scale Standard Deviation 0.67	0.0 units on a scale Standard Deviation 0.00
Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 6	0.0 units on a scale Standard Deviation 0.00	0.2 units on a scale Standard Deviation 0.40
Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 2	0.0 units on a scale Standard Deviation 0.00	0.2 units on a scale Standard Deviation 0.39
Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 4	0.0 units on a scale Standard Deviation 0.00	0.2 units on a scale Standard Deviation 0.58
Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 26	-0.5 units on a scale Standard Deviation 1.41	0.0 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

BAS: clinician rated scale to assess akathisia by determining the degree of subjective restlessness and distress associated with restlessness. Global clinical assessment of akathisia subscale score of BAS, was rated on a 6-point scale range 0 (no symptoms) to 5 (maximum severity of symptoms); higher score indicates increased severity.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 1	0.0 units on a scale Standard Deviation 0.00	-0.1 units on a scale Standard Deviation 0.29
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 2	0.0 units on a scale Standard Deviation 0.00	0.3 units on a scale Standard Deviation 1.07
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 26	0.0 units on a scale Standard Deviation 0.00	-0.2 units on a scale Standard Deviation 0.38
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Follow-up Visit	0.0 units on a scale Standard Deviation 0.00	-0.3 units on a scale Standard Deviation 0.58
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Baseline	0.0 units on a scale Standard Deviation 0.00	0.2 units on a scale Standard Deviation 0.38
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 4	0.0 units on a scale Standard Deviation 0.00	0.1 units on a scale Standard Deviation 0.29
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 6	0.0 units on a scale Standard Deviation 0.00	-0.2 units on a scale Standard Deviation 0.40
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 10	0.0 units on a scale Standard Deviation 0.00	-0.2 units on a scale Standard Deviation 0.40
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 14	0.0 units on a scale Standard Deviation 0.00	-0.2 units on a scale Standard Deviation 0.40
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 18	0.0 units on a scale Standard Deviation 0.00	-0.2 units on a scale Standard Deviation 0.40
Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 22	0.0 units on a scale Standard Deviation 0.00	-0.2 units on a scale Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

AIMS: clinician rated 12-item scale to document occurrences of dyskinesia in participants, specifically tardive dyskinesia. Items 1 to 10, scored as 0 (none) to 4 (severe); higher score indicates greater severity. Items 11 to 12 are questions with No or Yes response. Only the sum of the first 7 items were calculated to evaluate AIMS movement cluster subscale score, giving it a possible score range of 0 (none) to 28 (maximum severity), higher scores indicate greater severity. Rows with only non-zero data/values for change in AIMS-movement cluster subscale score at specified time points, for at least 1 reporting arm, are reported below.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Movement Cluster Subscale Score of Abnormal Involuntary Movement Scale (AIMS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 6	0.0 units on a scale Standard Deviation 0.00	0.1 units on a scale Standard Deviation 0.30
Change From Baseline in Movement Cluster Subscale Score of Abnormal Involuntary Movement Scale (AIMS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Change at Week 2	0.0 units on a scale Standard Deviation 0.00	0.3 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

C-SSRS: a measure used to identify and assess participants at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior, preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods \[not plan\], without intent to act; active suicidal ideation with some intent to act, without specific plan; active suicidal ideation with specific plan and intent; self-injurious behavior, no suicidal intent). C-CASA categories with at least 1 participant, for specified time points, for at least 1 reporting arm are reported below.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) Week 10: Wish to be dead	0 Participants	1 Participants
Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) Week 6: Wish to be dead	0 Participants	1 Participants
Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) Week 26: Wish to be dead	0 Participants	1 Participants
Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) Week 26: Non-specific Active Suicidal Thoughts	0 Participants	1 Participants
Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) Week 26: Active Suicidal Thoughts With No Plan, Intent	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 26

CDRS-R: clinician-rated interview-based scale to assess 17 distinct symptom areas to derive an index of depression severity. Each symptom area was rated on a 7-point scale; range from 1 (no impairment) to 17 (maximum impairment). Total CDRS-R score was calculated as sum of responses for each 7 symptom areas. Total CDRS-R score ranged from 17 (no impairment) to 119 (maximum impairment); higher score indicated greater impairment.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26 Baseline	68.2 units on a scale Standard Deviation 16.40	67.7 units on a scale Standard Deviation 13.28
Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26 Change at Week 26	1.6 units on a scale Standard Deviation 11.60	7.2 units on a scale Standard Deviation 10.13

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 6, 14, 22, 26

YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26 Baseline	12.7 units on a scale Standard Deviation 8.31	12.0 units on a scale Standard Deviation 5.46
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26 Change at Week 1	0.6 units on a scale Standard Deviation 10.71	-5.5 units on a scale Standard Deviation 6.87
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26 Change at Week 2	-3.1 units on a scale Standard Deviation 5.90	-3.4 units on a scale Standard Deviation 7.42
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26 Change at Week 6	1.3 units on a scale Standard Deviation 10.01	-3.7 units on a scale Standard Deviation 7.71
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26 Change at Week 14	0.8 units on a scale Standard Deviation 8.84	-5.8 units on a scale Standard Deviation 3.95
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26 Change at Week 22	0.5 units on a scale Standard Deviation 9.19	-4.0 units on a scale Standard Deviation 7.29
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26 Change at Week 26	-1.9 units on a scale Standard Deviation 4.85	-6.4 units on a scale Standard Deviation 5.50

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. CGI-S score ranged from 1 (not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Baseline	2.7 units on a scale Standard Deviation 1.25	2.5 units on a scale Standard Deviation 0.97
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 1	0.3 units on a scale Standard Deviation 1.12	-0.3 units on a scale Standard Deviation 1.07
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Chang at Week 2	0.1 units on a scale Standard Deviation 1.21	-0.3 units on a scale Standard Deviation 0.98
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 4	0.0 units on a scale Standard Deviation 1.00	-0.2 units on a scale Standard Deviation 1.40
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 6	0.5 units on a scale Standard Deviation 1.38	0.0 units on a scale Standard Deviation 1.26
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 10	-0.2 units on a scale Standard Deviation 0.84	-0.1 units on a scale Standard Deviation 0.83
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 14	0.0 units on a scale Standard Deviation 1.00	-0.5 units on a scale Standard Deviation 1.04
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 18	-0.7 units on a scale Standard Deviation 1.15	-0.4 units on a scale Standard Deviation 1.12
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 22	-1.0 units on a scale Standard Deviation 1.41	-0.2 units on a scale Standard Deviation 1.14
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 Change at Week 26	-0.1 units on a scale Standard Deviation 1.25	-0.5 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Baseline (last measurement from A1281198), A1281201: Week 26

CGAS: a clinician-rated global assessment item for children, based on symptoms and social functioning in home, school, and community settings. Scores ranged from 1 (extremely impaired) to 100 (doing very well), where higher levels indicate better health.

Outcome measures

Outcome measures
Measure	Ziprasidone in A1281198 and A1281201 n=10 Participants Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 Participants Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26 Baseline	68.2 units on a scale Standard Deviation 16.40	67.7 units on a scale Standard Deviation 13.28
Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26 Change at Week 26	1.6 units on a scale Standard Deviation 11.60	7.2 units on a scale Standard Deviation 10.13

Adverse Events

Ziprasidone in A1281198 and A1281201

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo in A1281198 Then Ziprasidone in A1281201

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ziprasidone in A1281198 and A1281201 n=10 participants at risk Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight \>=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight \<45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	Placebo in A1281198 Then Ziprasidone in A1281201 n=13 participants at risk Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight \>45 kg) or Week 1 (with body weight \<45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
Psychiatric disorders Aggression	0.00% 0/10 • A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks) Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.	7.7% 1/13 • A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks) Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.
Psychiatric disorders Suicidal ideation	0.00% 0/10 • A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks) Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.	7.7% 1/13 • A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks) Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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