| Title | Analyses of treatment-emergent mania with olanzapine/fluoxetine combination in the treatment of bipolar depression. | | Author(s) | Keck PE, Corya SA, Altshuler LL, Ketter TA, McElroy SL, Case M, Briggs SD, Tohen M | | Institution | Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, OH 45267, USA. paul.keck@ic.edu | | Source | J Clin Psychiatry 2005 May; 66(5):611-6. | | MeSH | Adult
Antipsychotic Agents
Benzodiazepines
Bipolar Disorder
Comparative Study
Double-Blind Method
Drug Therapy, Combination
Female
Fluoxetine
Humans
Male
Placebos
Psychiatric Status Rating Scales
Research Support, Non-U.S. Gov't
Risk Factors
Serotonin Uptake Inhibitors
Severity of Illness Index
Treatment Outcome
| | Abstract | BACKGROUND: Treatment-emergent mania is a potential risk when patients with bipolar disorder are treated with antidepressant agents. These subanalyses compare treatment-emergent mania rates in bipolar I depressed patients treated with olanzapine, placebo, or olanzapine/fluoxetine combination.
METHOD: In this 8-week, double-blind investigation, patients with bipolar I depression (DSM-IV criteria) (N = 833, baseline Montgomery-Asberg Depression Rating Scale total score > or = 20) were randomly assigned to olanzapine (5-20 mg/day, N = 370), placebo (N = 377), or olanzapine/fluoxetine combination (6/25, 6/50, or 12/50 mg/day; N = 86). Treatment-emergent mania was evaluated with the Young Mania Rating Scale (YMRS), the Clinical Global Impressions-Bipolar Edition (CGI-BP) Severity of Mania scale, and adverse events records.
RESULTS: Overall rates of study discontinuation due to mania were low and not significantly different among the therapy groups (p = .358). Incidence of treatment-emergent mania (defined as a YMRS score < 15 at baseline and > or = 15 at any subsequent visit) did not differ significantly among therapy groups (olanzapine 5.7%, placebo 6.7%, olanzapine/fluoxetine combination 6.4%; p = .861). Subjects receiving olanzapine or olanzapine/fluoxetine combination had greater mean decreases in YMRS scores than those receiving placebo (p < .001 for both). Subjects receiving olanzapine or olanzapine/fluoxetine combination also had greater mean decreases in CGI-BP scores than those receiving placebo (p = .040 and p = .003, respectively).
CONCLUSION: These results suggest that olanzapine/fluoxetine combination does not present a greater risk of treatment-emergent mania compared to olanzapine or placebo over 8 weeks of acute treatment for bipolar I depression. Due to the cyclical nature of bipolar disorder, patients taking olanzapine/fluoxetine combination for bipolar depression should still be monitored for signs or symptoms of emerging mania. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Randomized Controlled Trial
| | PubMed ID | 15889948 |
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