Trial Outcomes & Findings for High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms (NCT NCT00403546)

Results Overview

Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

131 participants

Primary outcome timeframe

From Baseline up to Week 8

Results posted on

2017-06-06

Participant Flow

Upon signing informed consent participants not already taking ziprasidone were instructed to start open-label ziprasidone for 3 weeks. Of 131 participants who signed informed consent 75 started ziprasidone and 56 were already on ziprasidone. Those completing open-label and those on ziprasidone were then screened.

Participant milestones

Participant milestones
Measure	Standard Treatment Ziprasidone Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day \[160 mg/d\]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial. Participants who were already taking standard treatment ziprasidone for 3 weeks or longer at time of enrollment were eligible for screening, as well.	High-Dose Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Signed Informed Consent/Open-Label STARTED	131	0	0
Signed Informed Consent/Open-Label COMPLETED	103	0	0
Signed Informed Consent/Open-Label NOT COMPLETED	28	0	0
Screening Phase STARTED	103	0	0
Screening Phase COMPLETED	75	0	0
Screening Phase NOT COMPLETED	28	0	0
Randomized Trial STARTED	0	38	37
Randomized Trial COMPLETED	0	21	21
Randomized Trial NOT COMPLETED	0	17	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Treatment Ziprasidone Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day \[160 mg/d\]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial. Participants who were already taking standard treatment ziprasidone for 3 weeks or longer at time of enrollment were eligible for screening, as well.	High-Dose Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Signed Informed Consent/Open-Label Withdrew Consent	6	0	0
Signed Informed Consent/Open-Label Early Termination	8	0	0
Signed Informed Consent/Open-Label Terminated by Investigator	9	0	0
Signed Informed Consent/Open-Label Adverse Event	5	0	0
Screening Phase Screening Failure	22	0	0
Screening Phase Adverse Event	1	0	0
Screening Phase Terminated Prior to Randomization	5	0	0
Randomized Trial Early Terminations	0	17	16

Baseline Characteristics

High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.	Total n=75 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 12.0 • n=5 Participants	41.0 years STANDARD_DEVIATION 11.9 • n=7 Participants	40.0 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline up to Week 8

Population: All participants in the randomized trial.

Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial	633 side effect events	588 side effect events

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All study participants with available data at each time point.

The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS) Baseline	1.5 units on a scale Standard Deviation 2.0	1.5 units on a scale Standard Deviation 2.7
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS) Change from Baseline at Week 2	0.44 units on a scale Standard Deviation 1.93	-0.65 units on a scale Standard Deviation 2.21
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS) Change from Baseline at Week 4	0.46 units on a scale Standard Deviation 2.08	-0.35 units on a scale Standard Deviation 2.12
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS) Change from Baseline at Week 6	0.59 units on a scale Standard Deviation 3.06	-0.09 units on a scale Standard Deviation 2.41
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS) Change from Baseline at Week 8	-0.10 units on a scale Standard Deviation 2.49	-0.10 units on a scale Standard Deviation 2.02

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All participants who had available data at each time point.

BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0 - 3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0 - 5. Total score ranges from 0 to 14 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in the Barnes Akathisia Scale (BAS) Baseline	1.2 units on a scale Standard Deviation 2.2	1.4 units on a scale Standard Deviation 2.4
Change From Baseline in the Barnes Akathisia Scale (BAS) Change from Baseline at Week 2	0.00 units on a scale Standard Deviation 2.61	0.13 units on a scale Standard Deviation 1.69
Change From Baseline in the Barnes Akathisia Scale (BAS) Change from Baseline at Week 4	-0.27 units on a scale Standard Deviation 2.88	-0.48 units on a scale Standard Deviation 2.17
Change From Baseline in the Barnes Akathisia Scale (BAS) Change from Baseline at Week 6	-0.95 units on a scale Standard Deviation 2.46	-0.45 units on a scale Standard Deviation 2.11
Change From Baseline in the Barnes Akathisia Scale (BAS) Change from Baseline at Week 8	-0.62 units on a scale Standard Deviation 2.09	-0.29 units on a scale Standard Deviation 2.15

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: All participants with available data at each time point.

Blood samples were taken at baseline and Week 8 to measure serum prolactin concentrations. Normal range for females (non-pregnant) is 2-29 nanograms per deciliter (ng/dL) and for males 2-18 ng/dL. Values above the normal range were reported as High and values below the normal range were reported as Low. Reported here is the number of participants with high prolactin concentration and the number of participants with low prolactin concentration.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Number of Participants With High and Low Levels in Serum Prolactin Concentration High Prolactin at Baseline	9 participants	10 participants
Number of Participants With High and Low Levels in Serum Prolactin Concentration High Prolactin up to Week 8	7 participants	6 participants
Number of Participants With High and Low Levels in Serum Prolactin Concentration Low Prolactin at Baseline	1 participants	1 participants
Number of Participants With High and Low Levels in Serum Prolactin Concentration Low Prolactin up to Week 8	1 participants	0 participants

PRIMARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

Population: All participants with available data at each time point.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at regular times during the study. Normal SBP is defined as 120 millimeters of mercury (mmHg) or below and normal DBP is defined as 80 mmHg or below. Change from baseline is indicated for each time point. A positive change from baseline indicates and increase in blood pressure and a negative change from baseline indicates a decrease.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Vital Signs: Systolic and Diastolic Blood Pressure Levels SBP Baseline	123.2 mmHg Standard Deviation 14.5	125.0 mmHg Standard Deviation 15.3
Vital Signs: Systolic and Diastolic Blood Pressure Levels SBP Week 1	123.9 mmHg Standard Deviation 13.58	122.3 mmHg Standard Deviation 15.14
Vital Signs: Systolic and Diastolic Blood Pressure Levels SBP Week 2	124.5 mmHg Standard Deviation 14.23	124.9 mmHg Standard Deviation 16.09
Vital Signs: Systolic and Diastolic Blood Pressure Levels SBP Week 4	124.8 mmHg Standard Deviation 16.47	124.3 mmHg Standard Deviation 16.92
Vital Signs: Systolic and Diastolic Blood Pressure Levels SBP Week 6	122.5 mmHg Standard Deviation 18.63	127.3 mmHg Standard Deviation 13.64
Vital Signs: Systolic and Diastolic Blood Pressure Levels SBP Week 8	125.1 mmHg Standard Deviation 16.76	121.3 mmHg Standard Deviation 11.73
Vital Signs: Systolic and Diastolic Blood Pressure Levels DBP Baseline	77.63 mmHg Standard Deviation 11.49	78.43 mmHg Standard Deviation 9.30
Vital Signs: Systolic and Diastolic Blood Pressure Levels DBP Week 1	77.18 mmHg Standard Deviation 9.10	76.56 mmHg Standard Deviation 8.59
Vital Signs: Systolic and Diastolic Blood Pressure Levels DBP Week 2	79.24 mmHg Standard Deviation 10.12	77.81 mmHg Standard Deviation 12.16
Vital Signs: Systolic and Diastolic Blood Pressure Levels DBP Week 4	78.08 mmHg Standard Deviation 11.36	79.17 mmHg Standard Deviation 10.47
Vital Signs: Systolic and Diastolic Blood Pressure Levels DBP Week 6	77.73 mmHg Standard Deviation 14.61	82.18 mmHg Standard Deviation 12.98
Vital Signs: Systolic and Diastolic Blood Pressure Levels DBP Week 8	79.24 mmHg Standard Deviation 12.84	75.67 mmHg Standard Deviation 9.70

PRIMARY outcome

Timeframe: 6 hours after dosing of Weeks 1, 2 and 8

Population: All participants with available data at each time point.

QT interval is a measure of the time between the start of the Q wave and the end of the T wave as determined by electrocardiogram (EKG). The corrected QT Interval (QTc) adjusts the QT interval for heart rate. The number of participants with an increase to QTc interval \>/= 500 msec was reported.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=34 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec) Week 1	0 participants	1 participants
Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec) Week 2	0 participants	0 participants
Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec) Week 8	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All participants with available data at each time point.

The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Total PANSS score consists of 7 items in the Negative subscale, 7 items in the Positive subscale and 16 items in the General Psychopathology scale. Total PANSS score ranges from 30 to 210. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Baseline	74.7 units on a scale Standard Deviation 16.1	71.9 units on a scale Standard Deviation 12.6
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Change from Baseline at Week 2	-4.03 units on a scale Standard Deviation 7.65	-4.16 units on a scale Standard Deviation 9.92
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Change from Baseline at Week 4	-5.08 units on a scale Standard Deviation 6.91	-6.87 units on a scale Standard Deviation 9.51
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Change from Baseline at Week 6	-8.73 units on a scale Standard Deviation 9.48	-4.32 units on a scale Standard Deviation 11.36
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Change from Baseline at Week 8	-8.62 units on a scale Standard Deviation 7.79	-5.48 units on a scale Standard Deviation 10.59

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All participants with available data at each time point

Response was defined as a reduction in the PANSS total score from baseline by 20% or greater, calculated by first subtracting 30 (the PANSS minimum possible total score). Response rate is the percentage of participants with a response.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=33 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=31 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Percentage of Participants With Response Week 2	24.2 percentage of participants	38.7 percentage of participants
Percentage of Participants With Response Week 4	23.1 percentage of participants	60.9 percentage of participants
Percentage of Participants With Response Week 6	36.4 percentage of participants	31.8 percentage of participants
Percentage of Participants With Response Week 8	33.3 percentage of participants	42.9 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All participants with available data at each time point.

AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score Baseline	0.6 units on a scale Standard Deviation 1.2	1.3 units on a scale Standard Deviation 2.4
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score Change from Baseline at Week 2	0.00 units on a scale Standard Deviation 1.09	-0.53 units on a scale Standard Deviation 1.50
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score Change from Baseline at Week 4	0.46 units on a scale Standard Deviation 1.63	-0.43 units on a scale Standard Deviation 2.11
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score Change from Baseline at Week 6	0.55 units on a scale Standard Deviation 1.18	0.18 units on a scale Standard Deviation 1.44
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score Change from Baseline at Week 8	0.90 units on a scale Standard Deviation 1.95	0.10 units on a scale Standard Deviation 2.07

PRIMARY outcome

Timeframe: From Baseline up to Week 8

Population: Safety population includes all participants who received at least one dose of study medication.

Adverse event: any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Serious adverse event (SAE): significant hazard, contraindication, side effect, or precaution, which fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Number of Treatment-emergent Adverse Events During Randomized Trial Serious Adverse Events	4 adverse events	3 adverse events
Number of Treatment-emergent Adverse Events During Randomized Trial Non-serious Adverse Events	85 adverse events	95 adverse events

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All participants with available data at each time point.

The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Positive symptoms as defined by the American Psychiatric Association refer to an excess or distortion of normal functions and include the following 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in Positive Subscale Score of PANSS Baseline	19.6 units on a scale Standard Deviation 5.5	18.2 units on a scale Standard Deviation 5.1
Change From Baseline in Positive Subscale Score of PANSS Change from Baseline at Week 2	-1.30 units on a scale Standard Deviation 3.25	-0.90 units on a scale Standard Deviation 3.25
Change From Baseline in Positive Subscale Score of PANSS Change from Baseline at Week 4	-2.08 units on a scale Standard Deviation 3.19	-1.57 units on a scale Standard Deviation 3.36
Change From Baseline in Positive Subscale Score of PANSS Change from Baseline at Week 6	-3.09 units on a scale Standard Deviation 3.75	-0.91 units on a scale Standard Deviation 3.15
Change From Baseline in Positive Subscale Score of PANSS Change from Baseline at Week 8	-3.24 units on a scale Standard Deviation 3.35	-1.52 units on a scale Standard Deviation 3.01

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All participants with available data at each time point.

The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Negative symptoms as defined by the American Psychiatric Association represent a diminution or loss of normal functions and include the following 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in PANSS Negative Subscale Score Baseline	18.1 units on a scale Standard Deviation 5.8	17.9 units on a scale Standard Deviation 5.3
Change From Baseline in PANSS Negative Subscale Score Change from Baseline at Week 2	-0.30 units on a scale Standard Deviation 2.70	-1.16 units on a scale Standard Deviation 4.66
Change From Baseline in PANSS Negative Subscale Score Change from Baseline at Week 4	-1.04 units on a scale Standard Deviation 2.14	-2.04 units on a scale Standard Deviation 5.80
Change From Baseline in PANSS Negative Subscale Score Change from Baseline at Week 6	-1.59 units on a scale Standard Deviation 4.02	-1.68 units on a scale Standard Deviation 5.45
Change From Baseline in PANSS Negative Subscale Score Change from Baseline at Week 8	-1.90 units on a scale Standard Deviation 2.98	-1.52 units on a scale Standard Deviation 5.72

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

Population: All participants with available data at each time point.

The CDRS was used to assess the level of depression in participants with schizophrenia. The questionnaire consists of 9 questions rated on a 4-point scale from 0 to 3. Total range is 0 to 27 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score Baseline	3.8 units on a scale Standard Deviation 3.9	4.9 units on a scale Standard Deviation 4.2
Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score Change from Baseline at Week 2	-0.72 units on a scale Standard Deviation 3.32	-1.61 units on a scale Standard Deviation 3.78
Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score Change from Baseline at Week 4	0.19 units on a scale Standard Deviation 3.72	-1.83 units on a scale Standard Deviation 3.90
Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score Change from Baseline at Week 6	-0.32 units on a scale Standard Deviation 3.64	-2.45 units on a scale Standard Deviation 4.01
Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score Change from Baseline at Week 8	-0.62 units on a scale Standard Deviation 4.57	-2.14 units on a scale Standard Deviation 3.84

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All participants with available data at each time point.

CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score Baseline	4.1 units on a scale Standard Deviation 0.7	4.3 units on a scale Standard Deviation 0.6
Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score Change from Baseline at Week 8	-0.25 units on a scale Standard Deviation 0.72	-0.05 units on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All participants with available data at each time point.

CGI-I is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to baseline. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=29 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=22 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score Baseline	3.8 units on a scale Standard Deviation 0.5	3.9 units on a scale Standard Deviation 0.9
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score Change from Baseline at Week 8	-0.57 units on a scale Standard Deviation 0.94	-0.43 units on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All participants with available data at each time point.

GAF is a numeric scale used to rate social, occupational, and psychological functioning of participants. Scores range from 100 (extremely high functioning) to 1 (severely impaired). A positive change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=38 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=36 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change From Baseline in Global Assessment of Functioning (GAF) Score Baseline	44.4 units on a scale Standard Deviation 12.3	49.0 units on a scale Standard Deviation 14.7
Change From Baseline in Global Assessment of Functioning (GAF) Score Change from Baseline at Week 8	3.24 units on a scale Standard Deviation 7.76	4.86 units on a scale Standard Deviation 11.28

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All participants with available data at each time point.

SCoRS is a 20 item interview-based clinical assessment that evaluates cognitive deficits and the degree to which these deficits impair participants' day-to-day functioning. The following cognitive domains are assessed: attention, memory, working memory, language production, reasoning, problem solving, motor skills, and social cognition. Score ranges from 1 to 10 with a higher score indicating a greater degree of impairment. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	High-Dose Ziprasidone n=37 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone n=35 Participants Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Change in Schizophrenia Cognition Rating Scale (SCoRS) Score Baseline	4.9 units on a scale Standard Deviation 1.5	4.3 units on a scale Standard Deviation 1.6
Change in Schizophrenia Cognition Rating Scale (SCoRS) Score Change from Baseline at Week 8	-0.75 units on a scale Standard Deviation 0.85	0.25 units on a scale Standard Deviation 1.77

Adverse Events

Standard Treatment Ziprasidone Open-label Phase

Serious events: 4 serious events

Other events: 37 other events

Deaths: 0 deaths

Standard Treatment Ziprasidone Screening Phase

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

High-Dose Ziprasidone Randomized Trial

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo, Standard Treatment Ziprasidone Randomized Trial

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Treatment Ziprasidone Open-label Phase n=131 participants at risk Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day \[160 mg/d\]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial.	Standard Treatment Ziprasidone Screening Phase n=103 participants at risk Participants who had taken standard treatment ziprasidone for 3 weeks or longer were eligible for screening to enter the randomized trial.	High-Dose Ziprasidone Randomized Trial n=38 participants at risk Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.	Placebo, Standard Treatment Ziprasidone Randomized Trial n=37 participants at risk Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Psychiatric disorders Hostility	0.76% 1/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.97% 1/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Psychiatric disorders Psychosis	0.76% 1/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	2.7% 1/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Psychiatric disorders Suicidal ideation	0.76% 1/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	2.6% 1/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	2.7% 1/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Psychiatric disorders Drug abuse	0.76% 1/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Surgical and medical procedures Psychosocial support	0.00% 0/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.97% 1/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Nervous system disorders Facial paresis	0.00% 0/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	2.6% 1/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Immune system disorders Asthma	0.00% 0/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	2.6% 1/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Psychiatric disorders Paranoia	0.00% 0/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	2.7% 1/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.
Psychiatric disorders Hallucination	0.00% 0/131 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/103 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	2.6% 1/38 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.	0.00% 0/37 • During open-label phase, screening phase and randomized trial from signing of informed consent up to approximately 12 weeks for participants who initiated ziprasidone as part of the open label phase and 9 weeks for participants who entered directly into the screening phase and randomized trial.

Other adverse events

Additional Information

Donald C. Goff, MD

Massachusetts General Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place