Trial · NCT00931723
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43) | Change in YMRS total score from baseline to Day 43. | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Number of Patients With Clinically Significant Response. | 43 days (from baseline to Day 43) | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Participants | NUMBER |
| SECONDARY | Remission | Days 8 to 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Participants | NUMBER |
| SECONDARY | Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness) | Change from baseline to Day 43. | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase) | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Improvement of Overall Bipolar Illness | Day 43. | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Participants | NUMBER |
| SECONDARY | Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Change from baseline to Day 43. | Scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in PANSS Activation Subscale Score | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in PANSS Positive Subscale Score | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 1 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 2 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 3 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 4 | Change from baseline to Day 43 | Scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 5 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 6 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 7 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 8 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 9 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Each YMRS Item Score No. 10 | Change from baseline to Day 43 | 173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores). | Scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00931723/outcomes