Trial · NCT01256177
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
NCT01256177, Phase 3, Completed, AstraZeneca; results first posted 2016-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression. Trials, record NCT01256177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256177
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
- NCT number
- NCT01256177
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 361 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Bipolar Depression
- Interventions
- Quetiapine Fumarate (SEROQUEL) Extended Release, Placebo
- First posted
- 2010-12-08
- Last updated
- 2016-04-15
- Results first posted
- 2016-02-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline to Week 8 | MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | 8 weeks from baseline | Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | After 8 week of start of treatment | Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12 |
| Secondary | Change From Baseline to Each Assessment in MADRS Total Score | Baseline to Week 8 | MADRS total score range: 0 to 60, the higher the score, the more severe. |
| Secondary | Change From Baseline to Week 8 in HAM-D Total Scores | Baseline to Week 8 | HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline |
| Secondary | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | Baseline to Week 8 | CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease |
| Secondary | The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved | After 8 weeks of start of treatment | Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "much" or "Very much" improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved. |
| Secondary | Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation | Baseline to Week 8 | MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline |
| Secondary | Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment) | After 8 weeks of start of treatment | The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline to Week 8 | Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114) | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | 8 weeks from baseline | Full Analysis set | Participants | NUMBER |
| SECONDARY | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | After 8 week of start of treatment | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Change From Baseline to Each Assessment in MADRS Total Score | Baseline to Week 8 | Full Analysis Set (Number of participants at each assessment : Baseline (Placebo=140, Quetiapine XR= 139), Week 1 (Placebo=140, Quetiapine XR= 139), Week 2 (Placebo=127, Quetiapine XR= 128), Week 4 (Placebo=114, Quetiapine XR= 120), Week 6 (Placebo=102, Quetiapine XR= 114), Week 8 (Placebo=100, Quetiapine XR= 114)). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 in HAM-D Total Scores | Baseline to Week 8 | Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | Baseline to Week 8 | Full Anlaysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=112) | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved | After 8 weeks of start of treatment | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation | Baseline to Week 8 | Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114) | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment) | After 8 weeks of start of treatment | Full Analysis Set | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Placebo | Change from Baseline to End of Study | -15.27 | Standard Error 0.81 | Scores on a scale |
| Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Quetiapine XR | Change from Baseline to End of Study | -18.48 | Standard Error 0.78 | Scores on a scale |
| Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Placebo | Baseline | 28.8 | Standard Error 0.45 | Scores on a scale |
| Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Quetiapine XR | Baseline | 28.5 | Standard Error 0.46 | Scores on a scale |
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | Placebo | 62 | Participants | ||
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | Quetiapine XR | 93 | Participants | ||
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | Placebo | 59 | Participants | ||
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | Quetiapine XR | 88 | Participants | ||
| Change From Baseline to Each Assessment in MADRS Total Score | Placebo | Change from Baseline to Week 1 | -4.14 | Standard Error 0.50 | Scores on a scale |
| Change From Baseline to Each Assessment in MADRS Total Score | Quetiapine XR | Change from Baseline to Week 1 | -5.62 | Standard Error 0.51 | Scores on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 148 | |
| Overall Study | STARTED | Quetiapine XR | 148 | |
| Overall Study | COMPLETED | Placebo | 98 | |
| Overall Study | COMPLETED | Quetiapine XR | 111 | |
| Overall Study | NOT COMPLETED | Placebo | 50 | |
| Overall Study | NOT COMPLETED | Quetiapine XR | 37 |
Source ClinicalTrials.gov
Adverse events22
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 | PLACEBO | 4 | 147 | 5 |
| other | CONSTIPATION | Gastrointestinal disorders | QUETIAPINE XR | 17 | 147 | 17 |
| other | DRY MOUTH | Gastrointestinal disorders | PLACEBO | 7 | 147 | 7 |
| other | DRY MOUTH | Gastrointestinal disorders | QUETIAPINE XR | 21 | 147 | 22 |
| other | NAUSEA | Gastrointestinal disorders | PLACEBO | 10 | 147 | 10 |
| other | NAUSEA | Gastrointestinal disorders | QUETIAPINE XR | 3 | 147 | 3 |
| other | FATIGUE | General disorders | PLACEBO | 2 | 147 | 3 |
| other | FATIGUE | General disorders | QUETIAPINE XR | 13 | 147 | 14 |
| other | NASOPHARYNGITIS | Infections and infestations | PLACEBO | 10 | 147 | 10 |
| other | NASOPHARYNGITIS | Infections and infestations | QUETIAPINE XR | 3 | 147 | 3 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLACEBO | ||
| Total, all-cause mortality | QUETIAPINE XR | ||
| Total, other adverse events | PLACEBO | 43 | 147 |
| Total, other adverse events | QUETIAPINE XR | 81 | 147 |
| Total, serious adverse events | PLACEBO | 3 | 147 |
| Total, serious adverse events | QUETIAPINE XR | 0 | 147 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26911380 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Quetiapine XR vs Placebo: The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved | Trial comparisons |
| Quetiapine XR vs Placebo: Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment) | Trial comparisons |
| Quetiapine XR vs Placebo: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | Trial comparisons |
| Quetiapine XR vs Placebo: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | Trial comparisons |
| QUETIAPINE XR vs PLACEBO: 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/NCT01256177
GET https://conductscience.org/api/trials/v1/NCT01256177/results?page=2