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

26-WEEK OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (MOST RECENT EPISODE MANIC)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03768726

Enrollment

Registered

2018-12-07

Start date

2018-12-21

Completion date

2020-07-31

Last updated

2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Brief summary

This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic).

Detailed description

Study A1281201 is a 6 month, open label extension study of the ongoing double blind, randomized, placebo controlled study of ziprasidone in pediatric Bipolar Disorder (Study A1281198). Study A1281201 will enroll adolescents aged 10 to 17 years with Bipolar I Disorder who have participated in double blind Study A1281198. In order to be enrolled in this open label extension trial, subjects must have met the enrollment criteria for Study A1281198, and must meet the inclusion and exclusion criteria for Study A1281201 at the extension study Baseline visit (last visit in the double blind study). The purpose of adding this extension study to the ongoing Geodon pediatric bipolar program is to obtain additional longer term safety data in children and adolescents with Bipolar I disorder treated with ziprasidone.

Interventions

DRUGZiprasidone

All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.

DRUGPlacebo

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Subjects who participate in A1281198 will be transitioned under double blind conditions (during the first two weeks of the study) to 26 weeks of treatment with flexibly dosed opened label ziprasidone.

Intervention model description

Subjects would completed A1281198 will be transitioned under double blind conditions to 26 weeks of treatment with flexibly dosed opened label ziprasidone.

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Evidence of personally signed and dated informed consent document by the legal representative and an assent document by the subject . * Subjects and their legal guardians who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * The subjects must have received investigational product in Study A1281198 before entering this open label extension. * In the investigator's opinion, the subject must be likely to benefit from antipsychotic therapy . * All fertile male subjects and female subjects of childbearing potential who are sexually active and/or their legal guardians, as appropriate, must agree that a highly effective method of contraception

Exclusion criteria

* Any subjects from the preceding double blind trail who experienced a serious adverse event which required study medication to be discontinued and the subject to be withdrawn from the study. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persistent Fridericia's correction (QTcF) \>480 msec or increase from baseline QTcF \>60 msec) during the preceding study. * Subjects requiring any medications not allowed by the Concomitant Medication Table 12 (see Concomitant Treatment(s)). * Subjects who require treatment with drugs that are known to consistently prolong the QT interval (see Concomitant Medication Table 12). * Subjects who are judged by the investigator as being at imminent risk of suicide. * Subjects living in the same home as another study participant or having the same caregiver during the same enrollment period (Such subjects can be enrolled in the study at different times but may not be in the study at the same time). * Subjects should be excluded or a risk assessment should be done to verify that it is safe for the subject to participate in the trial if the subject's responses on the C SSRS or other information based on the investigator's judgment indicate: * Suicide ideation associated with actual intent and a method or plan such that a positive response ('Yes') is made on items 4 or 5 of the suicidal ideation subscale of the C SSRS; or * Any suicide behaviors such that a determination of 'yes' is made to any of the suicide behavior items of the C SSRS. * Pregnant female subjects, breastfeeding female subjects. * Participation in other studies other than the preceding Study. * Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)	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.

Secondary

Measure	Time frame	Description
Number of Participants With Physical Examination Abnormalities at Baseline and Week 26	Baseline (last measurement from A1281198), Week 26 of A1281201	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.
Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit	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 in sitting and standing systolic and diastolic blood pressure in millimeter of mercury (mmHg) was reported.
Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit	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.
Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	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.
Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit	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.
Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit	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.
Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit	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.
Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit	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.
Number of Participants With Laboratory Abnormalities	A1281201: Day 1 up to 1 Week after last dose of study medication (maximum up to 27 Weeks)	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.
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 (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.
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 (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.
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	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.
Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)	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.
Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26	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.
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	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.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26	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.
Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26	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.
Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit	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 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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
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 \>=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.	10
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.	13
Total	23

Withdrawals & dropouts

Period	Reason	FG000	FG001
Follow-Up	Adverse Event	2	2
Follow-Up	Other	1	0
Follow-Up	Withdrawal By Parent/Guardian	1	1
Follow-Up	Withdrawal by Subject	2	0
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

Baseline characteristics

Characteristic	Placebo in A1281198 Then Ziprasidone in A1281201	Total	Ziprasidone in A1281198 and A1281201
Age, Continuous	14.2 years STANDARD_DEVIATION 2	14.1 years STANDARD_DEVIATION 2.1	14.0 years STANDARD_DEVIATION 2.3
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants	22 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	10 Participants	18 Participants	8 Participants
Sex: Female, Male Female	7 Participants	12 Participants	5 Participants
Sex: Female, Male Male	6 Participants	11 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 13
other Total, other adverse events	7 / 10	12 / 13
serious Total, serious adverse events	0 / 10	1 / 13

Outcome results

Primary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Ziprasidone in A1281198 and A1281201	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	7 Participants
Ziprasidone in A1281198 and A1281201	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	0 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	12 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	1 Participants

Secondary

Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

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

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 7.23
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 9.62
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 7.23
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 10.69
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	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	-3.00 mmHg	Standard Deviation 2.828
Placebo in A1281198 Then Ziprasidone in A1281201	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	111.38 mmHg	Standard Deviation 11.384
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.00 mmHg	Standard Deviation 11.505
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.08 mmHg	Standard Deviation 10.431
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.83 mmHg	Standard Deviation 8.321
Placebo in A1281198 Then Ziprasidone in A1281201	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	-3.45 mmHg	Standard Deviation 11.903
Placebo in A1281198 Then Ziprasidone in A1281201	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	-3.09 mmHg	Standard Deviation 11.674
Placebo in A1281198 Then Ziprasidone in A1281201	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	-7.09 mmHg	Standard Deviation 8.949
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.82 mmHg	Standard Deviation 10.852
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.40 mmHg	Standard Deviation 11.568
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.23 mmHg	Standard Deviation 14.219
Placebo in A1281198 Then Ziprasidone in A1281201	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	7.67 mmHg	Standard Deviation 4.041
Placebo in A1281198 Then Ziprasidone in A1281201	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	111.38 mmHg	Standard Deviation 12.738
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.00 mmHg	Standard Deviation 8.161
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.33 mmHg	Standard Deviation 12.759
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.17 mmHg	Standard Deviation 11.707
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.00 mmHg	Standard Deviation 14.457
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.18 mmHg	Standard Deviation 11.391
Placebo in A1281198 Then Ziprasidone in A1281201	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	-4.55 mmHg	Standard Deviation 6.933
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.73 mmHg	Standard Deviation 13.342
Placebo in A1281198 Then Ziprasidone in A1281201	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	5.40 mmHg	Standard Deviation 13.006
Placebo in A1281198 Then Ziprasidone in A1281201	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	-5.33 mmHg	Standard Deviation 12.01
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.50 mmHg	Standard Deviation 4.95
Placebo in A1281198 Then Ziprasidone in A1281201	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	72.00 mmHg	Standard Deviation 9.256
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.67 mmHg	Standard Deviation 9.633
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.17 mmHg	Standard Deviation 8.376
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.17 mmHg	Standard Deviation 10.744
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.00 mmHg	Standard Deviation 13.176
Placebo in A1281198 Then Ziprasidone in A1281201	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	-7.09 mmHg	Standard Deviation 10.387
Placebo in A1281198 Then Ziprasidone in A1281201	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	-3.91 mmHg	Standard Deviation 10.094
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.27 mmHg	Standard Deviation 15.186
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.30 mmHg	Standard Deviation 9.019
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.46 mmHg	Standard Deviation 10.548
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.67 mmHg	Standard Deviation 8.145
Placebo in A1281198 Then Ziprasidone in A1281201	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	74.85 mmHg	Standard Deviation 4.93
Placebo in A1281198 Then Ziprasidone in A1281201	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	-4.45 mmHg	Standard Deviation 6.654
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.33 mmHg	Standard Deviation 4.924
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.67 mmHg	Standard Deviation 10.465
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.82 mmHg	Standard Deviation 7.91
Placebo in A1281198 Then Ziprasidone in A1281201	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	-4.36 mmHg	Standard Deviation 7.215
Placebo in A1281198 Then Ziprasidone in A1281201	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	-4.09 mmHg	Standard Deviation 7.516
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.91 mmHg	Standard Deviation 12.136
Placebo in A1281198 Then Ziprasidone in A1281201	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	-4.30 mmHg	Standard Deviation 10.646
Placebo in A1281198 Then Ziprasidone in A1281201	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	-4.33 mmHg	Standard Deviation 8.7

Secondary

Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit	Change at Follow-up Visit	1.54 kg/m^2	Standard Deviation 1.447
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit	Baseline	23.37 kg/m^2	Standard Deviation 4.709
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit	Change at Week 26	0.78 kg/m^2	Standard Deviation 1.8
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit	Change at Week 6	0.91 kg/m^2	Standard Deviation 2.234

Secondary

Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit

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.

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit	Change at Follow-up Visit	0.26 z-score	Standard Deviation 0.33
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit	Baseline	1.06 z-score	Standard Deviation 0.852
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit	Change at Week 26	0.11 z-score	Standard Deviation 0.506
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit	Change at Week 6	-0.02 z-score	Standard Deviation 0.511

Secondary

Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit	Baseline	57.76 kg	Standard Deviation 17.634
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit	Change at Follow-up Visit	4.68 kg	Standard Deviation 2.639
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit	Baseline	62.40 kg	Standard Deviation 19.375
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit	Change at Week 26	2.33 kg	Standard Deviation 4.431
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit	Change at Week 6	0.78 kg	Standard Deviation 2.53

Secondary

Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at 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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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 16.4
Ziprasidone in A1281198 and A1281201	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 11.6
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26	Baseline	67.7 units on a scale	Standard Deviation 13.28
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26	Change at Week 26	7.2 units on a scale	Standard Deviation 10.13

Secondary

Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at 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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26	Baseline	68.2 units on a scale	Standard Deviation 16.4
Ziprasidone in A1281198 and A1281201	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 11.6
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26	Baseline	67.7 units on a scale	Standard Deviation 13.28
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26	Change at Week 26	7.2 units on a scale	Standard Deviation 10.13

Secondary

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.4 units on a scale	Standard Deviation 1.12
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26	Baseline	2.5 units on a scale	Standard Deviation 0.97
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.1 units on a scale	Standard Deviation 0.83
Placebo in A1281198 Then Ziprasidone in A1281201	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 1.07
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.5 units on a scale	Standard Deviation 1.05
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.3 units on a scale	Standard Deviation 0.98
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.5 units on a scale	Standard Deviation 1.04
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 1.4
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 1.14
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.0 units on a scale	Standard Deviation 1.26

Secondary

Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

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.

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 21.3
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 20.7
Ziprasidone in A1281198 and A1281201	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	—
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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	—
Ziprasidone in A1281198 and A1281201	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 18.9
Ziprasidone in A1281198 and A1281201	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 12.6
Ziprasidone in A1281198 and A1281201	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	—
Ziprasidone in A1281198 and A1281201	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 14.8
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 15.3
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 13.9
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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	—
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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	—
Ziprasidone in A1281198 and A1281201	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	—
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.5 msec	Standard Deviation 5.05
Placebo in A1281198 Then Ziprasidone in A1281201	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	148.5 msec	Standard Deviation 14.47
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.4 msec	Standard Deviation 10.25
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.6 msec	Standard Deviation 9.17
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.2 msec	Standard Deviation 15.72
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.3 msec	Standard Deviation 11.69
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.1 msec	Standard Deviation 10.17
Placebo in A1281198 Then Ziprasidone in A1281201	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	4.0 msec	Standard Deviation 10.89
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.0 msec	Standard Deviation 9.42
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.7 msec	Standard Deviation 9.25
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.9 msec	Standard Deviation 12.7
Placebo in A1281198 Then Ziprasidone in A1281201	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	17.0 msec	—
Placebo in A1281198 Then Ziprasidone in A1281201	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	412.4 msec	Standard Deviation 18.87
Placebo in A1281198 Then Ziprasidone in A1281201	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	15.6 msec	Standard Deviation 21.74
Placebo in A1281198 Then Ziprasidone in A1281201	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	11.4 msec	Standard Deviation 24.01
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.9 msec	Standard Deviation 18.81
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.2 msec	Standard Deviation 27.75
Placebo in A1281198 Then Ziprasidone in A1281201	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	3.9 msec	Standard Deviation 24.2
Placebo in A1281198 Then Ziprasidone in A1281201	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	8.9 msec	Standard Deviation 30.94
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.5 msec	Standard Deviation 21.43
Placebo in A1281198 Then Ziprasidone in A1281201	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	-5.0 msec	—
Placebo in A1281198 Then Ziprasidone in A1281201	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	401.8 msec	Standard Deviation 18.57
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.3 msec	Standard Deviation 11.4
Placebo in A1281198 Then Ziprasidone in A1281201	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	14.0 msec	Standard Deviation 13.74
Placebo in A1281198 Then Ziprasidone in A1281201	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	5.8 msec	Standard Deviation 13.98
Placebo in A1281198 Then Ziprasidone in A1281201	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 12.87
Placebo in A1281198 Then Ziprasidone in A1281201	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	3.2 msec	Standard Deviation 18.94
Placebo in A1281198 Then Ziprasidone in A1281201	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	6.2 msec	Standard Deviation 12.62
Placebo in A1281198 Then Ziprasidone in A1281201	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	7.0 msec	Standard Deviation 21.21
Placebo in A1281198 Then Ziprasidone in A1281201	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	4.3 msec	Standard Deviation 17.51
Placebo in A1281198 Then Ziprasidone in A1281201	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	6.0 msec	—
Placebo in A1281198 Then Ziprasidone in A1281201	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	382.8 msec	Standard Deviation 35.86
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.2 msec	Standard Deviation 17.17
Placebo in A1281198 Then Ziprasidone in A1281201	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	10.8 msec	Standard Deviation 29.55
Placebo in A1281198 Then Ziprasidone in A1281201	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	-4.1 msec	Standard Deviation 26.25
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.1 msec	Standard Deviation 25.98
Placebo in A1281198 Then Ziprasidone in A1281201	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	9.0 msec	Standard Deviation 25.65
Placebo in A1281198 Then Ziprasidone in A1281201	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	10.6 msec	Standard Deviation 21.47
Placebo in A1281198 Then Ziprasidone in A1281201	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	4.1 msec	Standard Deviation 31.27
Placebo in A1281198 Then Ziprasidone in A1281201	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	7.2 msec	Standard Deviation 20.99
Placebo in A1281198 Then Ziprasidone in A1281201	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	26.0 msec	—
Placebo in A1281198 Then Ziprasidone in A1281201	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	873.6 msec	Standard Deviation 171.26
Placebo in A1281198 Then Ziprasidone in A1281201	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	-5.7 msec	Standard Deviation 102.47
Placebo in A1281198 Then Ziprasidone in A1281201	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	-17.7 msec	Standard Deviation 187.46
Placebo in A1281198 Then Ziprasidone in A1281201	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	-61.2 msec	Standard Deviation 179.08
Placebo in A1281198 Then Ziprasidone in A1281201	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	-26.9 msec	Standard Deviation 159.35
Placebo in A1281198 Then Ziprasidone in A1281201	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	40.6 msec	Standard Deviation 173.34
Placebo in A1281198 Then Ziprasidone in A1281201	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	33.2 msec	Standard Deviation 169.68
Placebo in A1281198 Then Ziprasidone in A1281201	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	-13.7 msec	Standard Deviation 208.06
Placebo in A1281198 Then Ziprasidone in A1281201	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	20.4 msec	Standard Deviation 111.79
Placebo in A1281198 Then Ziprasidone in A1281201	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	—
Placebo in A1281198 Then Ziprasidone in A1281201	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	85.8 msec	Standard Deviation 5.9
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.8 msec	Standard Deviation 3.41
Placebo in A1281198 Then Ziprasidone in A1281201	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	3.8 msec	Standard Deviation 5.64
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.7 msec	Standard Deviation 6.31
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.5 msec	Standard Deviation 5.25
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.9 msec	Standard Deviation 7.3
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.3 msec	Standard Deviation 6.6
Placebo in A1281198 Then Ziprasidone in A1281201	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 4.93
Placebo in A1281198 Then Ziprasidone in A1281201	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	11.0 msec	—

Secondary

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

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.

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.3 units on a scale	Standard Deviation 0.58
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.2 units on a scale	Standard Deviation 0.38
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.1 units on a scale	Standard Deviation 0.29
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.3 units on a scale	Standard Deviation 1.07
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.1 units on a scale	Standard Deviation 0.29
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 0.4
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 0.4
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 0.4
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 0.4
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 0.42
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.2 units on a scale	Standard Deviation 0.38

Secondary

Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 9.4
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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	—
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.3 beats per minute	Standard Deviation 16.99
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit	Baseline	71.5 beats per minute	Standard Deviation 14.12
Placebo in A1281198 Then Ziprasidone in A1281201	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	-3.9 beats per minute	Standard Deviation 14.49
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.2 beats per minute	Standard Deviation 9.09
Placebo in A1281198 Then Ziprasidone in A1281201	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	-13.0 beats per minute	—
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.4 beats per minute	Standard Deviation 16.12
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.6 beats per minute	Standard Deviation 15.23
Placebo in A1281198 Then Ziprasidone in A1281201	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	5.0 beats per minute	Standard Deviation 16.28
Placebo in A1281198 Then Ziprasidone in A1281201	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	-3.0 beats per minute	Standard Deviation 8.69
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.4 beats per minute	Standard Deviation 13.2

Secondary

Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Waist Circumference, Change at Follow-up Visit	2.01 cm	Standard Deviation 3.778
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Height, Baseline	161.69 cm	Standard Deviation 11.996
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Waist Circumference, Baseline	80.23 cm	Standard Deviation 13.981
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Height, Change at Week 6	0.77 cm	Standard Deviation 0.984
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Waist Circumference, Change at Week 26	1.29 cm	Standard Deviation 4.21
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Height, Change at Week 26	0.55 cm	Standard Deviation 1.535
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Waist Circumference, Change at Week 6	2.23 cm	Standard Deviation 7.527
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit	Height, Change at Follow-up Visit	2.42 cm	Standard Deviation 1.413

Secondary

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

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.

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.3 units on a scale	Standard Deviation 0.87
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.1 units on a scale	Standard Deviation 0.3

Secondary

Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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 9.27
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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 10.27
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit	Standing, Baseline	83.08 beats per minute	Standard Deviation 13.554
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.00 beats per minute	Standard Deviation 9.254
Placebo in A1281198 Then Ziprasidone in A1281201	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	8.08 beats per minute	Standard Deviation 11.782
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.00 beats per minute	Standard Deviation 9.789
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.00 beats per minute	Standard Deviation 10.954
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.18 beats per minute	Standard Deviation 14.098
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.91 beats per minute	Standard Deviation 13.308
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.09 beats per minute	Standard Deviation 10.606
Placebo in A1281198 Then Ziprasidone in A1281201	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	4.30 beats per minute	Standard Deviation 12.056
Placebo in A1281198 Then Ziprasidone in A1281201	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	-2.69 beats per minute	Standard Deviation 8.5787
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.67 beats per minute	Standard Deviation 12.858
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.09 beats per minute	Standard Deviation 11.709
Placebo in A1281198 Then Ziprasidone in A1281201	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	7.18 beats per minute	Standard Deviation 12.131
Placebo in A1281198 Then Ziprasidone in A1281201	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	1.27 beats per minute	Standard Deviation 17.641
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.70 beats per minute	Standard Deviation 13.857
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.20 beats per minute	Standard Deviation 12.017
Placebo in A1281198 Then Ziprasidone in A1281201	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	-6.00 beats per minute	Standard Deviation 10.914
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.30 beats per minute	Standard Deviation 13.639
Placebo in A1281198 Then Ziprasidone in A1281201	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	2.50 beats per minute	Standard Deviation 12.095
Placebo in A1281198 Then Ziprasidone in A1281201	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	-0.33 beats per minute	Standard Deviation 10.68
Placebo in A1281198 Then Ziprasidone in A1281201	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	-1.00 beats per minute	Standard Deviation 21.213
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit	Sitting, Baseline	73.38 beats per minute	Standard Deviation 11.701

Secondary

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

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.

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.2 units on a scale	Standard Deviation 0.4
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.0 units on a scale	Standard Deviation 0
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.2 units on a scale	Standard Deviation 0.58
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.0 units on a scale	Standard Deviation 0
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.0 units on a scale	Standard Deviation 0
Placebo in A1281198 Then Ziprasidone in A1281201	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	0.2 units on a scale	Standard Deviation 0.39

Secondary

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at 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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Ziprasidone in A1281198 and A1281201	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 5.9
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	Change at Week 26	-6.4 units on a scale	Standard Deviation 5.5
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	Baseline	12.0 units on a scale	Standard Deviation 5.46
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	Change at Week 1	-5.5 units on a scale	Standard Deviation 6.87
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	Change at Week 2	-3.4 units on a scale	Standard Deviation 7.42
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	Change at Week 6	-3.7 units on a scale	Standard Deviation 7.71
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	Change at Week 14	-5.8 units on a scale	Standard Deviation 3.95
Placebo in A1281198 Then Ziprasidone in A1281201	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26	Change at Week 22	-4.0 units on a scale	Standard Deviation 7.29

Secondary

Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

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.

Time frame: 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)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Ziprasidone in A1281198 and A1281201	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
Placebo in A1281198 Then Ziprasidone in A1281201	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	1 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	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	1 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	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	1 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	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	1 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	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	1 Participants

Secondary

Number of Participants With Laboratory Abnormalities

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.

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Ziprasidone in A1281198 and A1281201	Number of Participants With Laboratory Abnormalities	5 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	Number of Participants With Laboratory Abnormalities	11 Participants

Secondary

Number of Participants With Physical Examination Abnormalities at Baseline and Week 26

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Ziprasidone in A1281198 and A1281201	Number of Participants With Physical Examination Abnormalities at Baseline and Week 26	Baseline	0 Participants
Ziprasidone in A1281198 and A1281201	Number of Participants With Physical Examination Abnormalities at Baseline and Week 26	Week 26	0 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	Number of Participants With Physical Examination Abnormalities at Baseline and Week 26	Baseline	0 Participants
Placebo in A1281198 Then Ziprasidone in A1281201	Number of Participants With Physical Examination Abnormalities at Baseline and Week 26	Week 26	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit

Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit

Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit

Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26

Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 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 From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

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 From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit

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 From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

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 From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26

Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

Number of Participants With Laboratory Abnormalities

Number of Participants With Physical Examination Abnormalities at Baseline and Week 26