Trial · NCT00883493
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
NCT00883493, Phase 3, Completed, AstraZeneca; results first posted 2012-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression. Trials, record NCT00883493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00883493
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
- NCT number
- NCT00883493
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 421 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Acute Bipolar Depression
- Interventions
- Quetiapine fumarate XR, Lithium carbonate
- First posted
- 2009-04-17
- Last updated
- 2012-07-11
- Results first posted
- 2012-06-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Baseline, 8 weeks | The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks). The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. |
| Secondary | Response Rate for MADRS. | baseline, week 8 | Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. |
| Secondary | Hamilton Rating Scale for Depression (HAM-D) Total Score. | Baseline, 8 Weeks | The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8). HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression. |
| Secondary | Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | baseline, 8 weeks | The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8). The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as "anxious mood", "tension" or "fears". Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max). |
| Secondary | Change in the Clinical Global Impression Severity (CGI-S) Score. | baseline, 8 weeks | The reported mean change in the CGI-S score was calculated as baseline - week 8. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Secondary | Change in Young Mania Rating Scale (YMRS) Total Score. | baseline, 8 weeks | The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient's subjective report of his or hers clinical condition over the previous 48 hours. The mean change in YMRS Total score reported was calculated as baseline - week 8. 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 | Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score. | Baseline, 8 weeks | The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8. PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality. |
| Secondary | Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score. | baseline, 8 weeks | The mean change in (Q-LES-Q-Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8). The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life. |
| Secondary | Change in the Sheehan Disability Scale (SDS) Total Score. | baseline, 8 weeks | The mean change in the SDS Total score from baseline to week 8 (baseline- week 8). Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment. |
| Secondary | Treatment Satisfaction Questionnaire (TSQ) Scores. | baseline, 8 weeks | The 14-item TAQ questionnaire evaluates the patient's overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication. Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Baseline, 8 weeks | The analysis population was Per Protocol (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit. | scores on a scale | MEAN |
| SECONDARY | Response Rate for MADRS. | baseline, week 8 | The analysis population was Per Protocol (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit. | percentage of participants | NUMBER |
| SECONDARY | Hamilton Rating Scale for Depression (HAM-D) Total Score. | Baseline, 8 Weeks | The analysis population was Per Protocol (PP). | scores on a scale | MEAN |
| SECONDARY | Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | baseline, 8 weeks | The analysis population was Per Protocol (PP). | scores on a scale | MEAN |
| SECONDARY | Change in the Clinical Global Impression Severity (CGI-S) Score. | baseline, 8 weeks | The analysis population was Per Protocol (PP). | scores on a scale | MEAN |
| SECONDARY | Change in Young Mania Rating Scale (YMRS) Total Score. | baseline, 8 weeks | The analysis population was Per Protocol (PP). | scores on a scale | MEAN |
| SECONDARY | Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score. | Baseline, 8 weeks | The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going. | Scores on a scale | MEAN |
| SECONDARY | Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score. | baseline, 8 weeks | The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going. | scores on a scale | MEAN |
| SECONDARY | Change in the Sheehan Disability Scale (SDS) Total Score. | baseline, 8 weeks | The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going. | scores on a scale | MEAN |
| SECONDARY | Treatment Satisfaction Questionnaire (TSQ) Scores. | baseline, 8 weeks | The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Quetiapine XR | 23.7 | Standard Deviation 8.4 | scores on a scale | |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Quatiapine XR + Lithium | 24.3 | Standard Deviation 7.9 | scores on a scale | |
| Response Rate for MADRS. | Quetiapine XR | 93.2 | 5,0 | percentage of participants | |
| Response Rate for MADRS. | Quatiapine XR + Lithium | 92.9 | 4,3 | percentage of participants | |
| Hamilton Rating Scale for Depression (HAM-D) Total Score. | Quetiapine XR | 20.5 | Standard Deviation 7.0 | scores on a scale | |
| Hamilton Rating Scale for Depression (HAM-D) Total Score. | Quatiapine XR + Lithium | 21.0 | Standard Deviation 6.1 | scores on a scale | |
| Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Quetiapine XR | 17.5 | Standard Deviation 8.2 | scores on a scale | |
| Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Quatiapine XR + Lithium | 17.7 | Standard Deviation 8.2 | scores on a scale | |
| Change in the Clinical Global Impression Severity (CGI-S) Score. | Quetiapine XR | 3.1 | Standard Deviation 1.4 | scores on a scale | |
| Change in the Clinical Global Impression Severity (CGI-S) Score. | Quatiapine XR + Lithium | 3.3 | Standard Deviation 1.2 | scores on a scale |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Quetiapine XR | 212 | |
| Overall Study | STARTED | Quatiapine XR + Lithium | 209 | |
| Overall Study | Intention To Treat Analysis Population | Quetiapine XR | 204 | |
| Overall Study | Intention To Treat Analysis Population | Quatiapine XR + Lithium | 195 | |
| Overall Study | Per Protocol Analysis Population | Quetiapine XR | 162 | |
| Overall Study | Per Protocol Analysis Population | Quatiapine XR + Lithium | 155 | |
| Overall Study | COMPLETED | Quetiapine XR | 166 | |
| Overall Study | COMPLETED | Quatiapine XR + Lithium | 159 | |
| Overall Study | NOT COMPLETED | Quetiapine XR | 46 | |
| Overall Study | NOT COMPLETED | Quatiapine XR + Lithium | 50 |
Source ClinicalTrials.gov
Adverse events42
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 | Dry mouth | Nervous system disorders | Quetiapine XR | 50 | 212 | |
| other | Dry mouth | Nervous system disorders | Quatiapine XR + Lithium | 47 | 209 | |
| other | Somnolance | Nervous system disorders | Quetiapine XR | 46 | 212 | |
| other | Somnolance | Nervous system disorders | Quatiapine XR + Lithium | 49 | 209 | |
| other | Headache | Nervous system disorders | Quetiapine XR | 28 | 212 | |
| other | Headache | Nervous system disorders | Quatiapine XR + Lithium | 25 | 209 | |
| other | Anxiety | Nervous system disorders | Quetiapine XR | 21 | 212 | |
| other | Anxiety | Nervous system disorders | Quatiapine XR + Lithium | 14 | 209 | |
| other | Constipation | Gastrointestinal disorders | Quetiapine XR | 20 | 212 | |
| other | Constipation | Gastrointestinal disorders | Quatiapine XR + Lithium | 17 | 209 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quetiapine XR | ||
| Total, all-cause mortality | Quatiapine XR + Lithium | ||
| Total, other adverse events | Quetiapine XR | 147 | 212 |
| Total, other adverse events | Quatiapine XR + Lithium | 149 | 209 |
| Total, serious adverse events | Quetiapine XR | 5 | 212 |
| Total, serious adverse events | Quatiapine XR + Lithium | 5 | 209 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Quetiapine XR vs Quatiapine XR + Lithium: serious adverse events |
Source 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.
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