Trial · NCT00282464
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
NCT00282464, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression. Trials, record NCT00282464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00282464
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
- NCT number
- NCT00282464
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 392 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Bipolar Disorder
- Interventions
- Placebo, Geodon (Ziprasidone)
- First posted
- 2006-01-26
- Last updated
- 2021-03-29
- Results first posted
- 2009-06-02
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline to Week 6 | Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6. |
| Secondary | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Baseline to Week 6 | Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) \& 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF) |
| Secondary | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Baseline to Week 3, Week 6 | Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 \& 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF. |
| Secondary | Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1 to Week 6 | Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) \& 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF. |
| Secondary | Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3, Week 6 | Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF. |
| Secondary | Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Baseline to Weeks 3, 6 | Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 \& 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF |
| Secondary | Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25) | Baseline to Weeks 3, 6 | Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 \& 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF. |
| Secondary | Change in Bech Melancholia Score | Baseline to Weeks 3, 6 | Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF. |
| Secondary | Change in Anxiety/Somatizations Factor Total Score | Baseline to Weeks 3, 6 | Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF. |
| Secondary | Change in Retardation Factor Scores | Baseline to Weeks 3, 6 | Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Baseline to Week 6 | Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF) | participants | NUMBER |
| SECONDARY | Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Baseline to Week 3, Week 6 | Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF) | Participants | NUMBER |
| SECONDARY | Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12 | Week 1 to Week 6 | Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF) | Participants | NUMBER |
| SECONDARY | Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7 | Week 3, Week 6 | Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF) | Participants | NUMBER |
| PRIMARY | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline to Week 6 | Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 - 6. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score | Baseline to Weeks 3, 6 | Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25) | Baseline to Weeks 3, 6 | Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Bech Melancholia Score | Baseline to Weeks 3, 6 | Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Anxiety/Somatizations Factor Total Score | Baseline to Weeks 3, 6 | Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Retardation Factor Scores | Baseline to Weeks 3, 6 | Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF). | score on scale | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Ziprasidone 20-80mg Bid | Week 1: Yes | 40 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Placebo | Week 1: Yes | 24 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Ziprasidone 20-80mg Bid | Week 1: No | 137 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Placebo | Week 1: No | 168 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Ziprasidone 20-80mg Bid | Week 2: Yes | 55 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Placebo | Week 2: Yes | 48 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Ziprasidone 20-80mg Bid | Week 2: No | 105 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Placebo | Week 2: No | 128 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Ziprasidone 20-80mg Bid | Week 3: Yes | 71 | participants | |
| Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score | Placebo | Week 3: Yes | 60 | participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ziprasidone 20-80mg Bid | 185 | |
| Overall Study | STARTED | Placebo | 196 | |
| Overall Study | COMPLETED | Ziprasidone 20-80mg Bid | 112 | |
| Overall Study | COMPLETED | Placebo | 134 | |
| Overall Study | NOT COMPLETED | Ziprasidone 20-80mg Bid | 73 | |
| Overall Study | NOT COMPLETED | Placebo | 62 |
Source ClinicalTrials.gov
Adverse events28
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 | Diarrhoea | Gastrointestinal disorders | Ziprasidone 20-80mg Bid | 8 | 185 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 15 | 196 | |
| other | Nausea | Gastrointestinal disorders | Ziprasidone 20-80mg Bid | 11 | 185 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 21 | 196 | |
| other | Fatigue | General disorders | Ziprasidone 20-80mg Bid | 13 | 185 | |
| other | Fatigue | General disorders | Placebo | 8 | 196 | |
| other | Dizziness | Nervous system disorders | Ziprasidone 20-80mg Bid | 12 | 185 | |
| other | Dizziness | Nervous system disorders | Placebo | 10 | 196 | |
| other | Headache | Nervous system disorders | Ziprasidone 20-80mg Bid | 21 | 185 | |
| other | Headache | Nervous system disorders | Placebo | 21 | 196 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ziprasidone 20-80mg Bid | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ziprasidone 20-80mg Bid | 93 | |
| Total, other adverse events | Placebo | 73 | |
| Total, serious adverse events | Ziprasidone 20-80mg Bid | 3 | |
| Total, serious adverse events | Placebo | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23609405 | 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/NCT00282464
GET https://conductscience.org/api/trials/v1/NCT00282464/registered?page=2