Efficacy and Safety of Long-Term Fluoxetine Versus Lithium Monotherapy of Bipolar II Disorder: A Randomized, Double-Blind, Placebo-Substitution Study
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OBJECTIVE: The authors examined the safety and efficacy of long-term fluoxetine monotherapy, lithium monotherapy, and placebo therapy in preventing relapse and recurrence of bipolar type II major depressive episode. The authors hypothesized that fluoxetine monotherapy would be superior to lithium monotherapy with a similar hypomanic mood conversion rate. METHOD: Patients at least 18 years old who recovered from their major depressive episode during initial open-label fluoxetine monotherapy were randomly assigned to receive 50 weeks of double-blind monotherapy with fluoxetine at 10-40 mg/day, lithium at 300-1200 mg/day, or placebo. The primary outcome measure was time to relapse or recurrence. Secondary outcome measures included the proportion of patients remaining well and the frequency of hypomanic symptoms. RESULTS: There were no significant differences in clinical or demographic characteristics among the fluoxetine (N=28), lithium (N=26), and placebo (N=27) groups. The mean time to relapse was 249.9 days for the fluoxetine group, 156.4 days for the lithium group, and 186.9 days for the placebo group. The hazard of relapse was significantly lower with fluoxetine compared with lithium, and the estimated hazard of relapse with lithium was 2.5 times greater than with fluoxetine. There were no statistically significant or clinically meaningful differences in hypomanic symptoms among treatment groups over time. One patient taking fluoxetine and one patient taking placebo discontinued treatment because of hypomania. CONCLUSIONS: These findings suggest that long-term fluoxetine monotherapy may provide superior relapse-prevention benefit relative to lithium monotherapy after recovery from bipolar II major depressive episode without an increase in hypomanic mood conversion episodes.
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In a 50-week RCT, the mean time to relapse into depression was significantly longer for fluoxetine than for lithium or placebo.
“In a 50‐week RCT, the mean time to relapse into depression was significantly longer for fluoxetine than for lithium or placebo.”
From Canadian Network for Mood and Anxiety Treatments ( <scp>CANMAT</scp> ) and International Society for Bipolar Disorders ( <scp>ISBD</scp> ) 2018 guidelines for the management of patients with bipolar disorder (2018) · cites this paper as [469]
The Abstract (Method) describes a 50-week randomized trial, and Results (Relapse Prevention Efficacy) report a longer mean time to depressive relapse with fluoxetine than with either comparator. The fluoxetine–lithium relapse-hazard difference was significant (p=0.04), but the fluoxetine–placebo difference was not (p=0.1). Thus, the claim overstates the evidence by implying a significant difference against placebo. (LLM, conf=0.90)
Experimental — accuracy not yet measuredHead-to-head comparisons with antidepressants found that lithium was not as effective in preventing depressive relapse as fluoxetine or venlafaxine.
“In contrast, head‐to‐head comparisons with antidepressants (reviewed below) found that lithium was not as effective in preventing depressive relapse as fluoxetine or venlafaxine.469, 497”
In that 50-week fluoxetine RCT, hypomanic episodes occurred in a similarly low frequency in the three groups.
“Hypomanic episodes occurred in a similarly low frequency in the three groups.469”
In that 50-week fluoxetine RCT, patients had responded acutely to open-label fluoxetine, making the sample enriched for fluoxetine response.
“Patients had responded acutely to open‐label fluoxetine, making the sample enriched for fluoxetine response.”
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- Authors
- Amsterdam, J. D., & Shults, J.
- Affiliations
- University of Pennsylvania (US)
- Venue
- American Journal of Psychiatry
- Published
- 2010-07-01
- Volume
- 167
- Issue
- 7
- Pages
- 792-800
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- PMC
- PMC2896440
- OpenAlex
- W1991845876
- Cited by
- 149
- References
- 38
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 5 · 2023: 4 · 2022: 4 · 2021: 7 · 2020: 10 · 2019: 11 · 2018: 11 · 2017: 8 · 2016: 10 · 2015: 5 · 2014: 9 · 2013: 16 · 2012: 20
- FWCI
- 12.87
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health (MH 060353, R01MH080097, MH060998, R01MH060998, R01MH060353, MH077580, R34MH077580, MH080097)
- National Cancer Institute (R01CA096885)
- National Center for Complementary and Integrative Health (AT005074, R01AT005074)
- 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 II disorder, fluoxetine, lithium, monotherapy, relapse prevention, major depressive episode, hypomania, long-term maintenance therapy
- MeSH terms
- Adult, Aged, Aged, 80 and over, Antidepressive Agents, Bipolar Disorder, Double-Blind Method, Female, Fluoxetine, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Recurrence, Time Factors, Lithium Compounds, Sample Size, Antidepressive Agents, Second-Generation, Young Adult
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