Trial · NCT00265330
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
NCT00265330, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed). Trials, record NCT00265330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00265330
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
- NCT number
- NCT00265330
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Bipolar Disorder
- Interventions
- Ziprasidone oral capsules
- First posted
- 2005-12-14
- Last updated
- 2021-03-25
- Results first posted
- 2009-04-03
- 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 | Young Mania Rating Scale (YMRS) Total Score Change From Baseline | baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF) | YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132. |
| Primary | Clinical Global Impression of Severity (CGI-S) Change From Baseline | baseline and 26 Weeks; 26 Weeks LOCF | CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132). |
| Primary | Incidence of Lab Abnormalities | Week 26 | number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality. |
| Primary | Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol | Week 6, Week 26 | Mean Change: lab value at observation minus lab value at baseline. |
| Primary | Change in Hormones | Week 6, Week 26 | Mean Change: lab value at observation minus lab value at baseline |
| Primary | Mean Change From Baseline in Supine Systolic Blood Pressure | Week 1 through Week 26 | Mean Change: vital sign value at observation minus vital sign value at baseline |
| Primary | Mean Change From Baseline in Supine Diastolic Blood Pressure | Week 1 through Week 26 | Mean Change: vital sign value at observation minus vital sign value at baseline |
| Primary | Mean Change From Baseline in Supine Pulse Rates | Week 1 through Week 26 | Mean Change: vital sign value at observation minus vital sign value at baseline |
| Primary | Mean Change From Baseline in Standing Systolic Blood Pressure | Week 1 through Week 26 | Mean Change: vital sign value at observation minus vital sign value at baseline |
| Primary | Mean Change From Baseline in Standing Diastolic Blood Pressure | Week 1 through Week 26 | Mean Change: vital sign value at observation minus vital sign value at baseline |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Young Mania Rating Scale (YMRS) Total Score Change From Baseline | baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF) | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation) | score on scale | MEAN |
| PRIMARY | Clinical Global Impression of Severity (CGI-S) Change From Baseline | baseline and 26 Weeks; 26 Weeks LOCF | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation) | score on scale | MEAN |
| PRIMARY | Incidence of Lab Abnormalities | Week 26 | Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115) | participants | NUMBER |
| PRIMARY | Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol | Week 6, Week 26 | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.) | milligram /deciliter (mg/dL) | MEAN |
| PRIMARY | Change in Hormones | Week 6, Week 26 | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.) | nanogram/deciliter (ng/dL) | MEAN |
| PRIMARY | Mean Change From Baseline in Supine Systolic Blood Pressure | Week 1 through Week 26 | millimeters of mercury (mm Hg) | MEAN | |
| PRIMARY | Mean Change From Baseline in Supine Diastolic Blood Pressure | Week 1 through Week 26 | millimeters mercury (mm Hg) | MEAN | |
| PRIMARY | Mean Change From Baseline in Supine Pulse Rates | Week 1 through Week 26 | beats per minute | MEAN | |
| PRIMARY | Mean Change From Baseline in Standing Systolic Blood Pressure | Week 1 through Week 26 | mm Hg | MEAN | |
| PRIMARY | Mean Change From Baseline in Standing Diastolic Blood Pressure | Week 1 through Week 26 | mm Hg | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Young Mania Rating Scale (YMRS) Total Score Change From Baseline | Ziprasidone | Week 2 (n=153) | -3.8 | Standard Deviation 9.0 | score on scale |
| Young Mania Rating Scale (YMRS) Total Score Change From Baseline | Ziprasidone | Week 6 (n=122) | -4.0 | Standard Deviation 9.1 | score on scale |
| Young Mania Rating Scale (YMRS) Total Score Change From Baseline | Ziprasidone | Week 18 (n=76) | -6.3 | Standard Deviation 12.7 | score on scale |
| Young Mania Rating Scale (YMRS) Total Score Change From Baseline | Ziprasidone | Week 26 (n=69) | -6.1 | Standard Deviation 11.6 | score on scale |
| Young Mania Rating Scale (YMRS) Total Score Change From Baseline | Ziprasidone | Early Termination (n=59) | 1.5 | Standard Deviation 11.3 | score on scale |
| Young Mania Rating Scale (YMRS) Total Score Change From Baseline | Ziprasidone | Week 26-LOCF (n=153) | -3.3 | Standard Deviation 10.7 | score on scale |
| Clinical Global Impression of Severity (CGI-S) Change From Baseline | Ziprasidone | Week 1 (n=159) | -0.2 | Standard Deviation 0.9 | score on scale |
| Clinical Global Impression of Severity (CGI-S) Change From Baseline | Ziprasidone | Week 2 (n=150) | -0.5 | Standard Deviation 1.2 | score on scale |
| Clinical Global Impression of Severity (CGI-S) Change From Baseline | Ziprasidone | Week 6 (n=122) | -0.4 | Standard Deviation 1.1 | score on scale |
| Clinical Global Impression of Severity (CGI-S) Change From Baseline | Ziprasidone | Week 10 (n=99) | -0.7 | Standard Deviation 1.3 | score on scale |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 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 | 162 | |
| Overall Study | COMPLETED | Ziprasidone | 67 | |
| Overall Study | NOT COMPLETED | Ziprasidone | 95 |
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 | Abdominal pain upper | Gastrointestinal disorders | Ziprasidone | 15 | 162 | |
| other | Nausea | Gastrointestinal disorders | Ziprasidone | 13 | 162 | |
| other | Vomiting | Gastrointestinal disorders | Ziprasidone | 12 | 162 | |
| other | Fatigue | General disorders | Ziprasidone | 11 | 162 | |
| other | Dizziness | Nervous system disorders | Ziprasidone | 12 | 162 | |
| other | Headache | Nervous system disorders | Ziprasidone | 36 | 162 | |
| other | Sedation | Nervous system disorders | Ziprasidone | 43 | 162 | |
| other | Somnolence | Nervous system disorders | Ziprasidone | 38 | 162 | |
| other | Insomnia | Psychiatric disorders | Ziprasidone | 22 | 162 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ziprasidone | 9 | 162 |
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 | 123 | 162 |
| Total, serious adverse events | Ziprasidone | 17 | 162 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24111980 | 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/NCT00265330
GET https://conductscience.org/api/trials/v1/NCT00265330/results?page=2