Trial · NCT00510146
Olanzapine Treatment of Patients With Bipolar I Disorder
NCT00510146, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-05-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Olanzapine Treatment of Patients With Bipolar I Disorder. Trials, record NCT00510146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00510146
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olanzapine Treatment of Patients With Bipolar I Disorder
- NCT number
- NCT00510146
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 514 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Depression, Bipolar
- Interventions
- Olanzapine, Placebo
- First posted
- 2007-08-01
- Last updated
- 2011-05-26
- Results first posted
- 2011-05-26
Source ClinicalTrials.gov
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | Baseline, Endpoint (Week 6) | The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). |
| Secondary | Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase) | Endpoint (Week 6) | Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). |
| Secondary | Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase) | Baseline through Endpoint (Week 6) | Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). |
| Secondary | Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase) | Baseline, Endpoint (Week 6) | CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill). |
| Secondary | Percentage of Participants With Recovery (Acute Phase) | Baseline through Endpoint (Week 6 ) | Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). |
| Secondary | Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase) | Baseline, Endpoint (Week 6) | The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. |
| Secondary | Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase) | Baseline, Endpoint (Week 6) | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). |
| Secondary | Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase) | Endpoint (Week 6) | In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features. |
| Secondary | Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase) | Endpoint (Week 6) | In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes. |
| Secondary | Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase) | Endpoint (Week 6) | In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders. |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 registered outcomesOutcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | Baseline, Endpoint (Week 6) | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase) | Endpoint (Week 6) | Intention-to-treat (ITT) population; all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase) | Baseline through Endpoint (Week 6) | Intention-to-treat (ITT) population; all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase) | Baseline, Endpoint (Week 6) | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Recovery (Acute Phase) | Baseline through Endpoint (Week 6 ) | Intention-to-treat (ITT) population; all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase) | Baseline, Endpoint (Week 6) | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase) | Baseline, Endpoint (Week 6) | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase) | Endpoint (Week 6) | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase) | Endpoint (Week 6) | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase) | Endpoint (Week 6) | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | percentage of participants | NUMBER |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 outcomesResults by group245
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | Olanzapine | Baseline | 29.36 | Standard Deviation 5.71 | units on a scale |
| Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | Placebo | Baseline | 28.69 | Standard Deviation 6.33 | units on a scale |
| Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | Olanzapine | Change | -14.26 | Standard Deviation 9.73 | units on a scale |
| Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | Placebo | Change | -11.71 | Standard Deviation 11.09 | units on a scale |
| Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase) | Olanzapine | 52.5 | percentage of participants | ||
| Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase) | Placebo | 43.3 | percentage of participants | ||
| Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase) | Olanzapine | 53.9 | percentage of participants | ||
| Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase) | Placebo | 49.7 | percentage of participants | ||
| Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase) | Olanzapine | Baseline-Mania | 1.07 | Standard Deviation 0.29 | units on a scale |
| Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase) | Placebo | Baseline-Mania | 1.11 | Standard Deviation 0.35 | units on a scale |
1 to 10 of 245Source ClinicalTrials.gov
See all 245 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment | STARTED | Olanzapine | 343 | |
| Double-Blind Treatment | STARTED | Placebo | 171 | |
| Double-Blind Treatment | COMPLETED | Olanzapine | 267 | |
| Double-Blind Treatment | COMPLETED | Placebo | 122 | |
| Double-Blind Treatment | NOT COMPLETED | Olanzapine | 76 | |
| Double-Blind Treatment | NOT COMPLETED | Placebo | 49 | |
| Open-Label Treatment | STARTED | Olanzapine | 267 | |
| Open-Label Treatment | STARTED | Placebo | 122 | |
| Open-Label Treatment | COMPLETED | Olanzapine | 196 | |
| Open-Label Treatment | COMPLETED | Placebo | 96 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events120
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 | Constipation | Gastrointestinal disorders | Olanzapine | 19 | 343 | 21 |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 171 | 5 |
| other | Constipation | Gastrointestinal disorders | Olanzapine (Open Label Treatment Period | 6 | 389 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Olanzapine | 7 | 343 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 171 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Olanzapine (Open Label Treatment Period | 5 | 389 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Olanzapine | 18 | 343 | 18 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 6 | 171 | 6 |
| other | Dry mouth | Gastrointestinal disorders | Olanzapine (Open Label Treatment Period | 4 | 389 | 4 |
| other | Nausea | Gastrointestinal disorders | Olanzapine | 7 | 343 | 7 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olanzapine | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Olanzapine (Open Label Treatment Period | ||
| Total, other adverse events | Olanzapine | 238 | 343 |
| Total, other adverse events | Placebo | 88 | 171 |
| Total, other adverse events | Olanzapine (Open Label Treatment Period | 209 | 389 |
| Total, serious adverse events | Olanzapine | 6 | 343 |
| Total, serious adverse events | Placebo | 7 | 171 |
| Total, serious adverse events | Olanzapine (Open Label Treatment Period | 14 | 389 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT00510146
GET https://conductscience.org/api/trials/v1/NCT00510146/registered?page=2