Trial · NCT00257192

Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

NCT00257192, Phase 3, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-04-13

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ConductScience Library. Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia. Trials, record NCT00257192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00257192

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
NCT number: NCT00257192
Status: Terminated
Phases: Phase 3
Enrollment: 284 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Schizophrenia
Interventions: placebo, Ziprasidone oral capsules
First posted: 2005-11-22
Last updated: 2021-03-25
Results first posted: 2010-04-13
Limitations and caveats: The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6	Baseline, Week 6	BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
Secondary	Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6	Baseline, Week 6	CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6	Baseline, Week 6	PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Secondary	Change From Baseline in PANSS: Positive and Negative Subscales at Week 6	Baseline, Week 6	PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Secondary	Clinical Global Impression of Improvement (CGI-I) Score at Week 6	Baseline, Week 6	CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
Secondary	Change From Baseline in Children's Global Assessment Scale (CGAS)	Baseline, Week 2, Week 4, Week 6, Early termination (ET)	CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.
Secondary	Change From Baseline in Child Health Questionnaire (CHQ)	Baseline, Week 6, ET	CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Secondary	Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score	Baseline, Week 1 through Week 6	CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.
Secondary	Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score	Baseline, Week 1 through Week 6	CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.
Secondary	Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13	Baseline, Week 1 through Week 6	CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6	Baseline, Week 6	Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6	Baseline, Week 6	ITT; N=number of subjects with analyzable data at post-baseline observation.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6	Baseline, Week 6	ITT; N=number of subjects with analyzable data at post-baseline observation.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in PANSS: Positive and Negative Subscales at Week 6	Baseline, Week 6	ITT; N=number of subjects with analyzable data at post-baseline observation.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression of Improvement (CGI-I) Score at Week 6	Baseline, Week 6	ITT; N=number of subjects with analyzable data at post-baseline observation.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Children's Global Assessment Scale (CGAS)	Baseline, Week 2, Week 4, Week 6, Early termination (ET)	ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward \[LOCF\] imputation used for Week 6 LOCF timepoint.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Child Health Questionnaire (CHQ)	Baseline, Week 6, ET	ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score	Baseline, Week 1 through Week 6	ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score	Baseline, Week 1 through Week 6	ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13	Baseline, Week 1 through Week 6	ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.	scores on a scale	MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group428

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6	Ziprasidone		-14.16	Standard Error 0.78	scores on a scale
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6	Placebo		-12.35	Standard Error 1.05	scores on a scale
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6	Ziprasidone		-1.05	Standard Error 0.08	scores on a scale
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6	Placebo		-0.84	Standard Error 0.12	scores on a scale
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6	Ziprasidone		-23.58	Standard Error 1.42	scores on a scale
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6	Placebo		-21.01	Standard Error 1.73	scores on a scale
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6	Ziprasidone	Positive score	-7.22	Standard Error 0.44	scores on a scale
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6	Placebo	Positive score	-5.88	Standard Error 0.56	scores on a scale
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6	Ziprasidone	Negative score	-5.51	Standard Error 0.43	scores on a scale
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6	Placebo	Negative score	-5.09	Standard Error 0.51	scores on a scale

1 to 10 of 428Source ClinicalTrials.gov

See all 428 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ziprasidone	193
Overall Study	STARTED	Placebo	91
Overall Study	Received Study Treatment	Ziprasidone	193
Overall Study	Received Study Treatment	Placebo	90
Overall Study	COMPLETED	Ziprasidone	135
Overall Study	COMPLETED	Placebo	52
Overall Study	NOT COMPLETED	Ziprasidone	58
Overall Study	NOT COMPLETED	Placebo	39

Source ClinicalTrials.gov

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Ziprasidone	19	193
other	Nausea	Gastrointestinal disorders	Placebo	2	90
other	Vomiting	Gastrointestinal disorders	Ziprasidone	12	193
other	Vomiting	Gastrointestinal disorders	Placebo	3	90
other	Fatigue	General disorders	Ziprasidone	17	193
other	Fatigue	General disorders	Placebo	4	90
other	Overdose	Injury, poisoning and procedural complications	Ziprasidone	11	193
other	Overdose	Injury, poisoning and procedural complications	Placebo	4	90
other	Akathisia	Nervous system disorders	Ziprasidone	13	193
other	Akathisia	Nervous system disorders	Placebo	3	90

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ziprasidone
Total, all-cause mortality	Placebo
Total, other adverse events	Ziprasidone	110	193
Total, other adverse events	Placebo	27	90
Total, serious adverse events	Ziprasidone	9	193
Total, serious adverse events	Placebo	1	90

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24111983	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ziprasidone vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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