Trial · NCT00129220
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
NCT00129220, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder. Trials, record NCT00129220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00129220
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
- NCT number
- NCT00129220
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 224 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Bipolar Disorder
- Interventions
- olanzapine, haloperidol, placebo
- First posted
- 2005-08-11
- Last updated
- 2010-12-28
- Results first posted
- 2010-02-15
- Limitations and caveats
- Identified errors were corrected.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score | Baseline, 3 weeks | 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 6 Week Endpoint in Young Mania Rating Scale (YMRS) | Baseline, 6 weeks | 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 | Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol) | 6 weeks | Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100. |
| Secondary | Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness | Baseline, 6 weeks | A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Secondary | Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale | Baseline, 3 weeks, 6 weeks | A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Secondary | Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks | Baseline, 3 weeks, 6 weeks | Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. 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. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100. |
| Secondary | Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks | 3 weeks, 6 weeks | Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100. |
| Secondary | Percentage of Participants Who Switched to Symptomatic Depression | 3 weeks, 6 weeks | Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. 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 | Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS) | Baseline, 3 weeks, 6 weeks | Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42. |
| Secondary | Percentage of Participants Who Switched to Syndromic Depression | 3 weeks, 6 weeks | Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score | Baseline, 3 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS) | Baseline, 6 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol) | 6 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness | Baseline, 6 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale | Baseline, 3 weeks, 6 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks | Baseline, 3 weeks, 6 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | percentage of participants | NUMBER |
| SECONDARY | Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks | 3 weeks, 6 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Switched to Symptomatic Depression | 3 weeks, 6 weeks | Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had HAMD-17 total scores ≤7 at baseline. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS) | Baseline, 3 weeks, 6 weeks | Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Switched to Syndromic Depression | 3 weeks, 6 weeks | Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had manic (not mixed) episode at baseline. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group53
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 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score | Olanzapine | -12.6 | Standard Deviation 10.0 | units on a scale | |
| Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score | Haloperidol | -14.3 | Standard Deviation 11.4 | units on a scale | |
| Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score | Placebo | -6.8 | Standard Deviation 14.0 | units on a scale | |
| Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS) | Olanzapine | -16.0 | Standard Deviation 11.4 | units on a scale | |
| Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS) | Haloperidol | -14.7 | Standard Deviation 13.1 | units on a scale | |
| Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS) | Placebo | -10.1 | Standard Deviation 15.8 | units on a scale | |
| Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol) | Olanzapine | 44.2 | percentage of participants | ||
| Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol) | Haloperidol | 20.0 | percentage of participants | ||
| Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness | Olanzapine | -1.6 | Standard Deviation 1.5 | units on a scale | |
| Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness | Haloperidol | -1.3 | Standard Deviation 1.8 | units on a scale |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Period II | STARTED | Olanzapine | 105 | |
| Study Period II | STARTED | Haloperidol | 20 | |
| Study Period II | STARTED | Placebo | 99 | |
| Study Period II | Received at Least One Dose of Study Drug | Olanzapine | 104 | |
| Study Period II | Received at Least One Dose of Study Drug | Haloperidol | 20 | |
| Study Period II | Received at Least One Dose of Study Drug | Placebo | 97 | |
| Study Period II | COMPLETED | Olanzapine | 72 | |
| Study Period II | COMPLETED | Haloperidol | 8 | |
| Study Period II | COMPLETED | Placebo | 52 | |
| Study Period II | NOT COMPLETED | Olanzapine | 33 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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 | Asthenopia | Eye disorders | Olanzapine | 0 | 105 | 0 |
| other | Asthenopia | Eye disorders | Haloperidol | 0 | 20 | 0 |
| other | Asthenopia | Eye disorders | Placebo | 2 | 96 | 2 |
| other | Cheilitis | Gastrointestinal disorders | Olanzapine | 1 | 105 | 1 |
| other | Cheilitis | Gastrointestinal disorders | Haloperidol | 1 | 20 | 1 |
| other | Cheilitis | Gastrointestinal disorders | Placebo | 0 | 96 | 0 |
| other | Constipation | Gastrointestinal disorders | Olanzapine | 10 | 105 | 10 |
| other | Constipation | Gastrointestinal disorders | Haloperidol | 2 | 20 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 96 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Olanzapine | 1 | 105 | 1 |
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 | Haloperidol | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Olanzapine | 78 | 105 |
| Total, other adverse events | Haloperidol | 14 | 20 |
| Total, other adverse events | Placebo | 64 | 96 |
| Total, serious adverse events | Olanzapine | 1 | 105 |
| Total, serious adverse events | Haloperidol | 0 | 20 |
| Total, serious adverse events | Placebo | 3 | 96 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22134043 | 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/NCT00129220
GET https://conductscience.org/api/trials/v1/NCT00129220/results?page=2