Olanzapine/fluoxetine combination vs. lamotrigine in the 6-month treatment of bipolar I depression
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To determine the efficacy and tolerability of olanzapine/fluoxetine combination (OFC) compared with lamotrigine (Lam) for long-term treatment of bipolar I depression, this 25-wk, randomized, double-blind study compared OFC (6/25, 6/50, 12/25, or 12/50 mg/d, n=205) with Lam titrated to 200 mg/d (n=205) in patients with bipolar I disorder, depressed. A protocol-specified analysis of 7-wk outcomes was previously reported. Outcome measures included Clinical Global Impressions-Severity of Illness (CGI-S) (primary), Montgomery-Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS) scores. OFC-treated patients had significantly greater improvement than Lam-treated patients over 25 wk on CGI-S (p=0.008), MADRS (p=0.005), and YMRS (p<0.001) scores, and from baseline across visits from week 5 (titration complete) to the end of the study on CGI-S (p=0.043), MADRS (p=0.017), and YMRS (p=0.001) scores. Of patients in remission after the 7-wk acute phase, there was no significant difference between treatment groups in the incidence of relapse (MADRS >15, p=0.528). Rate of treatment-emergent mania was not significantly different by treatment (p=0.401). OFC-treated patients had more frequent (p<0.05) somnolence, increased appetite, dry mouth, sedation, weight gain, and tremor; Lam-treated patients had more frequent insomnia. There was a significant difference in incidence of treatment-emergent cholesterol > or = 240 (p<0.001) and in weight gain of > or = 7% (p<0.001) in favour of the Lam group. Patients with bipolar I depression had significantly greater symptom improvement over 25 wk on OFC compared with Lam. There was no treatment difference in incidence of relapse. OFC-treated patients had more treatment-emergent adverse events and greater incidence of weight gain and hypercholesterolaemia.
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The olanzapine/fluoxetine combination appears to maintain mood stability over a 6-month period in patients with bipolar depression who respond acutely to this combination.
“The olanzapine/fluoxetine combination appears to maintain mood stability over a 6‐month period in patients with bipolar depression who respond acutely to this combination (level 2).391”
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“To determine the efficacy and tolerability of olanzapine/fluoxetine combination (OFC) compared with lamotrigine (Lam) for long-term treatment of bipolar I depression, this 25-wk, randomized, double-blind study compared OFC (6/25, 6/50, 12/25, or 12/50 mg/d, n=205) with Lam titrated to 200 mg/d…”
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- [3]3. Brown E, McElroy SL, Keck Jr. PE, Deldar A, Adams DH, Tohen M, Williamson DJ (2006). A seven-week comparison of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. Journal of Clinical Psychiatry 67, 1025-1033.
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- Authors
- Brown, E., Dunner, D. L., McElroy, S. L., Keck, P. E., Adams, D. H., Degenhardt, E., Tohen, M., & Houston, J. P.
- Affiliations
- Eli Lilly (United States) (US)
- University of Cincinnati (US)
- Cincinnati VA Medical Center (US)
- Harvard University (US)
- Corresponding author
- Brown, Eileen
- Venue
- The International Journal of Neuropsychopharmacology
- Publisher
- Oxford University Press (OUP)
- Published
- 2008-12-11
- Volume
- 12
- Issue
- 06
- Pages
- 773
- ISSN
- 1461-1457 (ISSN-L)
- 1469-5111
- OpenAlex
- W2134480650
- Cited by
- 73
- References
- 24
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 2 · 2020: 2 · 2019: 1 · 2018: 3 · 2017: 1 · 2016: 4 · 2015: 7 · 2014: 8 · 2013: 7 · 2012: 7
- FWCI
- 5.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The International Journal of Neuropsychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Diabetes Association
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Stanley Medical Research Institute
- Neurocrine Biosciences
- National Institute of Mental Health
- UCB Pharma
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- bipolar I depression, olanzapine-fluoxetine combination, lamotrigine, long-term maintenance therapy, relapse, treatment-emergent mania, weight gain, hypercholesterolemia, adverse drug reactions, atypical antipsychotics, mood stabilizers
- MeSH terms
- Olanzapine, Lamotrigine, Adolescent, Adult, Benzodiazepines, Bipolar Disorder, Calcium Channel Blockers, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Fluoxetine, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Severity of Illness Index, Time Factors, Triazines, Treatment Outcome, Selective Serotonin Reuptake Inhibitors, Young Adult
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