Phase 3
Completed N=27
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Source: ClinicalTrials.gov NCT00857584 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score — -13.1; -6.6 score on a scale
Summary
Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
-13.1; -6.6 | — |
| SECONDARY The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
-9.5; -8.6 | — |
| SECONDARY The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
-16.1; -17.7 | — |
| SECONDARY The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
-19.4; -18.2 | — |
| SECONDARY The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score |
-0.79; -1.08 | — |
| SECONDARY The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score |
-1.36; -1.00 | — |
| SECONDARY The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score |
-2.09; -2.56 | — |
| SECONDARY The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score |
-2.9; -2.88 | — |
| SECONDARY The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score |
-13.4; -8.9 | — |
| SECONDARY The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score |
-13.1; -10.6 | — |
| SECONDARY Number of Patients Response at Week 1 |
4; 4 | — |
| SECONDARY Number of Patients With Response at Week 2 |
8; 2 | — |
| SECONDARY Number of Patients With Response at Week 4. |
8; 6 | — |
| SECONDARY Number of Patients With Response at Week 8. |
8; 5 | — |
| SECONDARY Number of Patients With Remission at Week 1. |
6; 5 | — |
| SECONDARY Number of Patients With Remission at Week 2. |
6; 5 | — |
| SECONDARY Number of Patients With Remission at Week 4. |
3; 3 | — |
| SECONDARY Number of Patients With Remission at Week 8. |
3; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)
- Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization
- Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed consent signed
Exclusion Criteria
- Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) diagnoses different from bipolar disorder I or II - Length of current depressive episode less than 2 weeks or more than 12 months
- Having been treated with more than one mood stabilizer or any mood stabilizer other than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A inductor/inhibitor within the 7 days period prior to randomization
Data sourced from ClinicalTrials.gov (NCT00857584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.