Phase 3
Completed N=421
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Acute Bipolar Depression
Source: ClinicalTrials.gov NCT00883493 ↗
Enrolled (actual)
421
Serious AEs
2.4%
Results posted
Jun 2012
Primary outcomePrimary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. — 23.7; 24.3 scores on a scale
Summary
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. |
23.7; 24.3 | — |
| SECONDARY Response Rate for MADRS. |
93.2; 92.9 | — |
| SECONDARY Hamilton Rating Scale for Depression (HAM-D) Total Score. |
20.5; 21.0 | — |
| SECONDARY Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
17.5; 17.7 | — |
| SECONDARY Change in the Clinical Global Impression Severity (CGI-S) Score. |
3.1; 3.3 | — |
| SECONDARY Change in Young Mania Rating Scale (YMRS) Total Score. |
2.3; 2.2 | — |
| SECONDARY Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score. |
3.7; 5.0 | — |
| SECONDARY Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score. |
-17.9; -18.8 | — |
| SECONDARY Change in the Sheehan Disability Scale (SDS) Total Score. |
14.4; 14.3 | — |
| SECONDARY Treatment Satisfaction Questionnaire (TSQ) Scores. |
42.7; 36.7; 68.7; 66.7; 41.7; 44.4 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
- The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
- The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12
Exclusion Criteria
- Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
- Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
- Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug
Data sourced from ClinicalTrials.gov (NCT00883493). 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.