Trial · NCT00789854
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
NCT00789854, Phase 3, Completed, AstraZeneca; results first posted 2012-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients. Trials, record NCT00789854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00789854
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
- NCT number
- NCT00789854
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 688 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Major Depressive Disorder, Treatment Resistant Depression
- Interventions
- Quetiapine XR, Lithium carbonate, SSRI/Venlafaxine
- First posted
- 2008-11-13
- Last updated
- 2012-05-23
- Results first posted
- 2012-05-23
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set) | 6 weeks treatment | Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status. |
| Primary | Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set) | 6 weeks of treatment | Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status. |
| Secondary | Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients | 6 weeks of treatment | Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. |
| Secondary | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure | 6 weeks of treatment | Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. |
| Secondary | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure | 6 weeks of treatment | Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. |
| Secondary | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8 | 6 weeks of treatment | Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. |
| Secondary | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12 | 6 weeks of treatment | Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. |
| Secondary | Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients | 6 week of treatments | Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better |
| Secondary | Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure | 6 weeks of treatment | Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better |
| Secondary | Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure | 6 weeks of treatment | Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set) | 6 weeks treatment | Analysis was 'per protocol'. Exclusion reason from analysis: Violation of exclusion/inclusion criteria; Non-compliance regarding prohibited concomitant medication, Total unavailability of MADRS score after randomization, Patient not treated with any dose of study drug after randomization, Non-compliance regarding titration to 300 mg quetiapine/d. | scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set) | 6 weeks of treatment | scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients | 6 weeks of treatment | Participants | NUMBER | |
| SECONDARY | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure | 6 weeks of treatment | Participants | NUMBER | |
| SECONDARY | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure | 6 weeks of treatment | Participants | NUMBER | |
| SECONDARY | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8 | 6 weeks of treatment | Participants | NUMBER | |
| SECONDARY | Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12 | 6 weeks of treatment | Participants | NUMBER | |
| SECONDARY | Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients | 6 week of treatments | Participants | NUMBER | |
| SECONDARY | Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure | 6 weeks of treatment | Participants | NUMBER | |
| SECONDARY | Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure | 6 weeks of treatment | Participants | NUMBER |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set) | Quetiapine XR Mono | -16.2 | Standard Error 0.843 | scores on a scale | |
| Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set) | Add-on Quetiapine XR | -17.2 | Standard Error 0.826 | scores on a scale | |
| Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set) | Add-on Lithium | -14.9 | Standard Error 0.97 | scores on a scale | |
| Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set) | Quetiapine XR Mono | -13.9 | Standard Error 0.806 | scores on a scale | |
| Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set) | Add-on Quetiapine XR | -15.1 | Standard Error 0.797 | scores on a scale | |
| Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set) | Add-on Lithium | -13.3 | Standard Error 0.801 | scores on a scale | |
| Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients | Quetiapine XR Mono | 53 | Participants | ||
| Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients | Add-on Quetiapine XR | 73 | Participants | ||
| Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients | Add-on Lithium | 60 | Participants | ||
| Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure | Quetiapine XR Mono | 22 | Participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Quetiapine XR Mono | 228 | |
| Overall Study | STARTED | Add-on Quetiapine XR | 231 | |
| Overall Study | STARTED | Add-on Lithium | 229 | |
| Overall Study | COMPLETED | Quetiapine XR Mono | 179 | |
| Overall Study | COMPLETED | Add-on Quetiapine XR | 196 | |
| Overall Study | COMPLETED | Add-on Lithium | 182 | |
| Overall Study | NOT COMPLETED | Quetiapine XR Mono | 49 | |
| Overall Study | NOT COMPLETED | Add-on Quetiapine XR | 35 | |
| Overall Study | NOT COMPLETED | Add-on Lithium | 47 |
Source ClinicalTrials.gov
Adverse events48
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 | Somnolence | Nervous system disorders | Quetiapine XR Mono | 22 | 228 | |
| other | Somnolence | Nervous system disorders | Add-on Quetiapine XR | 20 | 231 | |
| other | Somnolence | Nervous system disorders | Add-on Lithium | 0 | 229 | |
| other | Sedation | Nervous system disorders | Quetiapine XR Mono | 15 | 228 | |
| other | Sedation | Nervous system disorders | Add-on Quetiapine XR | 11 | 231 | |
| other | Sedation | Nervous system disorders | Add-on Lithium | 0 | 229 | |
| other | Tremor | Nervous system disorders | Quetiapine XR Mono | 0 | 228 | |
| other | Tremor | Nervous system disorders | Add-on Quetiapine XR | 0 | 231 | |
| other | Tremor | Nervous system disorders | Add-on Lithium | 15 | 229 | |
| other | Dizziness | Nervous system disorders | Quetiapine XR Mono | 11 | 228 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quetiapine XR Mono | ||
| Total, all-cause mortality | Add-on Quetiapine XR | ||
| Total, all-cause mortality | Add-on Lithium | ||
| Total, other adverse events | Quetiapine XR Mono | 93 | 228 |
| Total, other adverse events | Add-on Quetiapine XR | 90 | 231 |
| Total, other adverse events | Add-on Lithium | 41 | 229 |
| Total, serious adverse events | Quetiapine XR Mono | 5 | 228 |
| Total, serious adverse events | Add-on Quetiapine XR | 5 | 231 |
| Total, serious adverse events | Add-on Lithium | 2 | 229 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23810357 | 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
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The record and each of its lists are JSON, twenty rows a page. No key.
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