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A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression.
J Clin Psychiatry. 2006 Jul; 67(7):1025-33.JC

Abstract

OBJECTIVE

Determine the efficacy and tolerability of olanzapine/fluoxetine combination (OFC) for treatment of acute bipolar I depression compared with lamotrigine.

METHOD

The 7-week, acute phase of a randomized, double-blind study compared OFC (6/25, 6/50, 12/25, or 12/50 mg/day; N = 205) with lamotrigine ([LMG] titrated to 200 mg/day; N = 205) in patients with DSM-IV-diagnosed bipolar I disorder, depressed. The study was conducted from November 2003 to August 2004.

RESULTS

Completion rates were similar between treatments (OFC, 66.8% vs. LMG, 65.4%; p = .835). OFC-treated patients had significantly greater improvement than lamotrigine-treated patients in change from baseline across the 7-week treatment period on the Clinical Global Impressions-Severity of Illness scale (primary outcome) (p = .002, effect size = 0.26), Montgomery-Asberg Depression Rating Scale (MADRS) (p = .002, effect size = 0.24), and Young Mania Rating Scale total scores (p = .001, effect size = 0.24). Response rates did not significantly differ between groups when defined as > or = 50% reduction in MADRS score (OFC, 68.8% vs. LMG, 59.7%; p = .073). Time to response was significantly shorter for OFC-treated patients (median days [95% CI] = OFC, 17 [14 to 22] vs. LMG, 23 [21 to 34]; p = .010). There was a significant difference in incidence of "suicidal and self-injurious behavior" adverse events (OFC, 0.5% vs. LMG, 3.4%; p = .037). Somnolence, increased appetite, dry mouth, sedation, weight gain, and tremor occurred more frequently (p < .05) in OFC-treated patients than lamotrigine-treated patients. Weight, total cholesterol, and triglyceride levels were significantly elevated in OFC-treated patients compared with lamotrigine-treated patients (all p < or = .001).

CONCLUSIONS

Patients with acute bipolar I depression had statistically significantly greater improvement in depressive and manic symptoms, more treatment-emergent adverse events, greater weight gain, and some elevated metabolic factors with OFC than lamotrigine. Treatment differences were of modest size.

Authors+Show Affiliations

Lilly Research Laboratories, Indianapolis, IN, USA. ebrown@lilly.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16889444

Citation

Brown, Eileen B., et al. "A 7-week, Randomized, Double-blind Trial of Olanzapine/fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression." The Journal of Clinical Psychiatry, vol. 67, no. 7, 2006, pp. 1025-33.
Brown EB, McElroy SL, Keck PE, et al. A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. J Clin Psychiatry. 2006;67(7):1025-33.
Brown, E. B., McElroy, S. L., Keck, P. E., Deldar, A., Adams, D. H., Tohen, M., & Williamson, D. J. (2006). A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. The Journal of Clinical Psychiatry, 67(7), 1025-33.
Brown EB, et al. A 7-week, Randomized, Double-blind Trial of Olanzapine/fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression. J Clin Psychiatry. 2006;67(7):1025-33. PubMed PMID: 16889444.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. AU - Brown,Eileen B, AU - McElroy,Susan L, AU - Keck,Paul E,Jr AU - Deldar,Ahmed, AU - Adams,David H, AU - Tohen,Mauricio, AU - Williamson,Douglas J, PY - 2006/8/8/pubmed PY - 2006/8/31/medline PY - 2006/8/8/entrez SP - 1025 EP - 33 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 67 IS - 7 N2 - OBJECTIVE: Determine the efficacy and tolerability of olanzapine/fluoxetine combination (OFC) for treatment of acute bipolar I depression compared with lamotrigine. METHOD: The 7-week, acute phase of a randomized, double-blind study compared OFC (6/25, 6/50, 12/25, or 12/50 mg/day; N = 205) with lamotrigine ([LMG] titrated to 200 mg/day; N = 205) in patients with DSM-IV-diagnosed bipolar I disorder, depressed. The study was conducted from November 2003 to August 2004. RESULTS: Completion rates were similar between treatments (OFC, 66.8% vs. LMG, 65.4%; p = .835). OFC-treated patients had significantly greater improvement than lamotrigine-treated patients in change from baseline across the 7-week treatment period on the Clinical Global Impressions-Severity of Illness scale (primary outcome) (p = .002, effect size = 0.26), Montgomery-Asberg Depression Rating Scale (MADRS) (p = .002, effect size = 0.24), and Young Mania Rating Scale total scores (p = .001, effect size = 0.24). Response rates did not significantly differ between groups when defined as > or = 50% reduction in MADRS score (OFC, 68.8% vs. LMG, 59.7%; p = .073). Time to response was significantly shorter for OFC-treated patients (median days [95% CI] = OFC, 17 [14 to 22] vs. LMG, 23 [21 to 34]; p = .010). There was a significant difference in incidence of "suicidal and self-injurious behavior" adverse events (OFC, 0.5% vs. LMG, 3.4%; p = .037). Somnolence, increased appetite, dry mouth, sedation, weight gain, and tremor occurred more frequently (p < .05) in OFC-treated patients than lamotrigine-treated patients. Weight, total cholesterol, and triglyceride levels were significantly elevated in OFC-treated patients compared with lamotrigine-treated patients (all p < or = .001). CONCLUSIONS: Patients with acute bipolar I depression had statistically significantly greater improvement in depressive and manic symptoms, more treatment-emergent adverse events, greater weight gain, and some elevated metabolic factors with OFC than lamotrigine. Treatment differences were of modest size. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/16889444/A_7_week_randomized_double_blind_trial_of_olanzapine/fluoxetine_combination_versus_lamotrigine_in_the_treatment_of_bipolar_I_depression_ L2 - http://www.psychiatrist.com/jcp/article/pages/2006/v67n07/v67n0703.aspx DB - PRIME DP - Unbound Medicine ER -