Trial · NCT00931723
Adult Bipolar Mania
NCT00931723, Phase 4, Completed, AstraZeneca; results first posted 2012-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adult Bipolar Mania. Trials, record NCT00931723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00931723
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adult Bipolar Mania
- NCT number
- NCT00931723
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 356 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Acute Mania
- Interventions
- Quetiapine fumarate XR, Lithium, Placebo
- First posted
- 2009-07-02
- Last updated
- 2012-04-19
- Results first posted
- 2012-04-19
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). |
| Secondary | The Number of Patients With Clinically Significant Response. | 43 days (from baseline to Day 43) | The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. |
| Secondary | Remission | Days 8 to 43 | The number of patients with clinically significant remission (defined as YMRS total score ≤12) from Days 8 to 43) was calculated. The Young Mania Rating Scale total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). |
| 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. | The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity. |
| 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 | The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores \>4 indicate worsening, while scores \<4 indicate improvement. |
| Secondary | Improvement of Overall Bipolar Illness | Day 43. | The number of patients with a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment at Day 43 was calculated. The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores \>4 indicate worsening, while scores \<4 indicate improvement. |
| Secondary | Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Change from baseline to Day 43. | The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. |
| Secondary | Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score | Change from baseline to Day 43 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210.A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. |
| Secondary | Change From Baseline to Day 43 in PANSS Activation Subscale Score | Change from baseline to Day 43 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. |
| Secondary | Change From Baseline to Day 43 in PANSS Positive Subscale Score | Change from baseline to Day 43 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43) | Lithium+Quetiapine XR | -22.8 | Standard Error 0.706 | Scores on a scale | |
| Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43) | Placebo+Quetiapine XR | -20.1 | Standard Error 0.711 | Scores on a scale | |
| The Number of Patients With Clinically Significant Response. | Lithium+Quetiapine XR | 137 | Participants | ||
| The Number of Patients With Clinically Significant Response. | Placebo+Quetiapine XR | 120 | Participants | ||
| Remission | Lithium+Quetiapine XR | 125 | Participants | ||
| Remission | Placebo+Quetiapine XR | 105 | Participants | ||
| Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness) | Lithium+Quetiapine XR | -2.5 | Standard Error 0.079 | Scores on a scale | |
| Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness) | Placebo+Quetiapine XR | -2.2 | Standard Error 0.080 | Scores on a scale | |
| Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase) | Lithium+Quetiapine XR | 1.7 | Standard Error 0.085 | Scores on a scale | |
| Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase) | Placebo+Quetiapine XR | 1.9 | Standard Error 0.086 | Scores on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lithium+Quetiapine XR | 173 | |
| Overall Study | STARTED | Placebo+Quetiapine XR | 183 | |
| Overall Study | COMPLETED | Lithium+Quetiapine XR | 147 | |
| Overall Study | COMPLETED | Placebo+Quetiapine XR | 144 | |
| Overall Study | NOT COMPLETED | Lithium+Quetiapine XR | 26 | |
| Overall Study | NOT COMPLETED | Placebo+Quetiapine XR | 39 |
Source ClinicalTrials.gov
Adverse events38
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 | Tremor | Nervous system disorders | Lithium+Quetiapine XR | 27 | 173 | |
| other | Tremor | Nervous system disorders | Placebo+Quetiapine XR | 9 | 183 | |
| other | Somnolence | Nervous system disorders | Lithium+Quetiapine XR | 22 | 173 | |
| other | Somnolence | Nervous system disorders | Placebo+Quetiapine XR | 10 | 183 | |
| other | Dizziness | Nervous system disorders | Lithium+Quetiapine XR | 11 | 173 | |
| other | Dizziness | Nervous system disorders | Placebo+Quetiapine XR | 8 | 183 | |
| other | Headache | Nervous system disorders | Lithium+Quetiapine XR | 9 | 173 | |
| other | Headache | Nervous system disorders | Placebo+Quetiapine XR | 11 | 183 | |
| other | Sedation | Nervous system disorders | Lithium+Quetiapine XR | 5 | 173 | |
| other | Sedation | Nervous system disorders | Placebo+Quetiapine XR | 3 | 183 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium+Quetiapine XR | ||
| Total, all-cause mortality | Placebo+Quetiapine XR | ||
| Total, other adverse events | Lithium+Quetiapine XR | 106 | 173 |
| Total, other adverse events | Placebo+Quetiapine XR | 83 | 183 |
| Total, serious adverse events | Lithium+Quetiapine XR | 4 | 173 |
| Total, serious adverse events | Placebo+Quetiapine XR | 8 | 183 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25505693 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lithium+Quetiapine XR vs Placebo+Quetiapine XR: The Number of Patients With Clinically Significant Response. | Trial comparisons |
| Lithium+Quetiapine XR vs Placebo+Quetiapine XR: Remission | Trial comparisons |
| Lithium+Quetiapine XR vs Placebo+Quetiapine XR: Improvement of Overall Bipolar Illness | Trial comparisons |
| Lithium+Quetiapine XR vs Placebo+Quetiapine XR: serious adverse events | Trial comparisons |
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/NCT00931723
GET https://conductscience.org/api/trials/v1/NCT00931723/registered?page=2