Trial · NCT00265382
Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia
NCT00265382, Phase 3, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-05-19
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ConductScience Library. Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia. Trials, record NCT00265382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00265382
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia
- NCT number
- NCT00265382
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 221 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Schizophrenia
- Interventions
- Ziprasidone oral capsules
- First posted
- 2005-12-14
- Last updated
- 2021-03-03
- Results first posted
- 2010-05-19
- 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 outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 26 weeks | All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported. |
| Secondary | Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Baseline, Week 26, Early Termination (ET) | Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). |
| Secondary | Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score | Baseline, Weeks 2, 6, 18, 26, ET | 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, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | 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 CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales | Baseline, Weeks 6 and 26, ET | Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). |
| Secondary | Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index | Baseline, Weeks 6 and 26, ET | Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79). |
| Secondary | Change From Baseline in Simpson-Angus Rating Scale (SARS) | Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected. |
| Secondary | Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item | Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed. |
| Secondary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score | Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity. |
| Secondary | Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score | Baseline, Weeks 2, 6, 18, 26, ET | 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, excitement. Ratings anchored to improve consistency for 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 26 weeks | Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0% AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold. | participants | NUMBER |
| SECONDARY | Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Baseline, Week 26, Early Termination (ET) | Safety Analysis Set. N=number of subjects with analyzable data at baseline. Baseline data from Study A1281134 (NCT00257192) served as the baseline for A1281135. | participants | NUMBER |
| SECONDARY | Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score | Baseline, Weeks 2, 6, 18, 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score | Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales | Baseline, Weeks 6 and 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index | Baseline, Weeks 6 and 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Simpson-Angus Rating Scale (SARS) | Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item | Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score | Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score | Baseline, Weeks 2, 6, 18, 26, ET | Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point. | scores on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group250
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Ziprasidone | AEs | 137 | participants | |
| Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Ziprasidone | SAEs | 16 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, Week 26 (Stage 1) | 1 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, Week 26 (Stage 2) | 1 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, Week 26 (Stage 3) | 11 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, Week 26 (Stage 4) | 39 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, Week 26 (Stage 5) | 21 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, ET (Stage 1) | 0 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, ET (Stage 2) | 10 | participants | |
| Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment | Ziprasidone | Pubic Hair, ET (Stage 3) | 22 | participants |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ziprasidone | 221 | |
| Overall Study | COMPLETED | Ziprasidone | 76 | |
| Overall Study | NOT COMPLETED | Ziprasidone | 145 |
Source ClinicalTrials.gov
Adverse events26
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 | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Ziprasidone | 20 | 221 | |
| other | Somnolence | Nervous system disorders | Ziprasidone | 33 | 221 | |
| other | Tremor | Nervous system disorders | Ziprasidone | 14 | 221 | |
| other | Fatigue | General disorders | Ziprasidone | 11 | 221 | |
| other | Insomnia | Psychiatric disorders | Ziprasidone | 11 | 221 | |
| serious | Drug ineffective | General disorders | Ziprasidone | 1 | 221 | |
| serious | Dystonia | Nervous system disorders | Ziprasidone | 1 | 221 | |
| serious | Aggression | Psychiatric disorders | Ziprasidone | 1 | 221 | |
| serious | Agitation | Psychiatric disorders | Ziprasidone | 1 | 221 | |
| serious | Anxiety | Psychiatric disorders | Ziprasidone | 1 | 221 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ziprasidone | ||
| Total, other adverse events | Ziprasidone | 68 | 221 |
| Total, serious adverse events | Ziprasidone | 16 | 221 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00265382
GET https://conductscience.org/api/trials/v1/NCT00265382/results?page=2