Trial · NCT00280566
Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
NCT00280566, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed). Trials, record NCT00280566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00280566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
- NCT number
- NCT00280566
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 584 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Bipolar Mania, Bipolar Disorder
- Interventions
- Placebo, Ziprasidone Oral Capsule
- First posted
- 2006-01-23
- Last updated
- 2021-03-25
- Results first posted
- 2009-12-14
- Limitations and caveats
This is a maintenance of effect design using a survival analysis methodology. In such a design it may be difficult to interpret timepoint by timepoint treatment group comparisons in MRS, CGI-S, CGI-I, MADRS, and PANSS.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Intervention for a Mood Episode During Double Blind Period | Period 2: 24 weeks or time of early termination | Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart. |
| Secondary | Time to Discontinuation for Any Reason During Double Blind Period 2 | Period 2: 24 weeks or time of early termination | Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time. |
| Secondary | Modified Time to Intervention for a Mood Episode (TIME) | Period 2: Week 24 or time of early termination | Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart. |
| Secondary | Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality. |
| Secondary | Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill. |
| Secondary | Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse. |
| Secondary | Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal. |
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period | Period 2: Weeks 4 - 24 or time of early termination | Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme) |
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period | Period 2: Weeks 4 - 24 or time of early termination | Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme). |
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period | Period 2: Weeks 4 - 24 or time of early termination | Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Intervention for a Mood Episode During Double Blind Period | Period 2: 24 weeks or time of early termination | Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode. | Days | MEAN |
| SECONDARY | Time to Discontinuation for Any Reason During Double Blind Period 2 | Period 2: 24 weeks or time of early termination | Intent to Treat (ITT). Number of participants who discontinued was 43 and 57 for ziprasidone and placebo, respectively. | days | MEAN |
| SECONDARY | Modified Time to Intervention for a Mood Episode (TIME) | Period 2: Week 24 or time of early termination | Intent to Treat (ITT). 29 out of 127 ziprasidone subjects and 38 out of 111 placebo subjects met the modified criteria for an intervention for a mood episode | Days | MEAN |
| SECONDARY | Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively. | scores on scale | MEAN |
| SECONDARY | Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | Intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period | Period 2: Weeks 1 - 24 or time of early termination | Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period | Period 2: Weeks 4 - 24 or time of early termination | intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period | Period 2: Weeks 4 - 24 or time of early termination | intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period | Period 2: Weeks 4 - 24 or time of early termination | intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively. | scores on scale | MEAN |
Source ClinicalTrials.gov
Results by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Intervention for a Mood Episode During Double Blind Period | Ziprasidone | 172.159 | Standard Error 5.646 | Days | |
| Time to Intervention for a Mood Episode During Double Blind Period | Placebo | 143.133 | Standard Error 7.532 | Days | |
| Time to Discontinuation for Any Reason During Double Blind Period 2 | Ziprasidone | 153.526 | Standard Error 6.454 | days | |
| Time to Discontinuation for Any Reason During Double Blind Period 2 | Placebo | 123.313 | Standard Error 7.524 | days | |
| Modified Time to Intervention for a Mood Episode (TIME) | Ziprasidone | 168.145 | Standard Error 5.857 | Days | |
| Modified Time to Intervention for a Mood Episode (TIME) | Placebo | 140.325 | Standard Error 7.627 | Days | |
| Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period | Ziprasidone | Week 1 (n=121, 106) | -0.2 | Standard Deviation 3.0 | scores on scale |
| Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period | Placebo | Week 1 (n=121, 106) | 0.8 | Standard Deviation 5.1 | scores on scale |
| Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period | Ziprasidone | Week 2 (n=116, 95) | -0.4 | Standard Deviation 4.2 | scores on scale |
| Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period | Placebo | Week 2 (n=116, 95) | -0.1 | Standard Deviation 4.7 | scores on scale |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 Open Label Ziprasidone | STARTED | Period 1 Open Label Ziprasidone | 584 | |
| Period 1 Open Label Ziprasidone | STARTED | Ziprasidone | 0 | |
| Period 1 Open Label Ziprasidone | STARTED | Placebo | 0 | |
| Period 1 Open Label Ziprasidone | COMPLETED | Period 1 Open Label Ziprasidone | 241 | |
| Period 1 Open Label Ziprasidone | COMPLETED | Ziprasidone | 0 | |
| Period 1 Open Label Ziprasidone | COMPLETED | Placebo | 0 | |
| Period 1 Open Label Ziprasidone | NOT COMPLETED | Period 1 Open Label Ziprasidone | 343 | |
| Period 1 Open Label Ziprasidone | NOT COMPLETED | Ziprasidone | 0 | |
| Period 1 Open Label Ziprasidone | NOT COMPLETED | Placebo | 0 | |
| Period 2 Double Blind | STARTED | Period 1 Open Label Ziprasidone | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events81
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 | Nausea | Gastrointestinal disorders | Period 1 Open Label Ziprasidone | 42 | 584 | |
| other | Nausea | Gastrointestinal disorders | Ziprasidone | 0 | 127 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 112 | |
| other | Fatigue | General disorders | Period 1 Open Label Ziprasidone | 44 | 584 | |
| other | Fatigue | General disorders | Ziprasidone | 0 | 127 | |
| other | Fatigue | General disorders | Placebo | 0 | 112 | |
| other | Upper respiratory tract infection | Infections and infestations | Period 1 Open Label Ziprasidone | 0 | 584 | |
| other | Upper respiratory tract infection | Infections and infestations | Ziprasidone | 5 | 127 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 6 | 112 | |
| other | Akathisia | Nervous system disorders | Period 1 Open Label Ziprasidone | 47 | 584 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period 1 Open Label Ziprasidone | ||
| Total, all-cause mortality | Ziprasidone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Period 1 Open Label Ziprasidone | 362 | |
| Total, other adverse events | Ziprasidone | 22 | |
| Total, other adverse events | Placebo | 24 | |
| Total, serious adverse events | Period 1 Open Label Ziprasidone | 15 | |
| Total, serious adverse events | Ziprasidone | 3 | |
| Total, serious adverse events | Placebo | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20122373 | 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.
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