期刊
AMERICAN JOURNAL OF PSYCHIATRY
卷 170, 期 1, 页码 102-110出版社
AMER PSYCHIATRIC PUBLISHING, INC
DOI: 10.1176/appi.ajp.2012.12060751
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资金
- American Drug Utilization Review
- American Professional Society of ADHD and Related Disorders
- American Psychiatric Association
- American Society for Clinical Psychopharmacology
- Appliance Computing (Mindsite)
- AstraZeneca
- Basliea
- Baystate Medical Center
- Belvoir Publishing
- Brain Cells
- Brandeis University
- Bristol-Myers Squibb
- Columbia University
- Corcept
- Dainippon Sumitomo
- Eli Lilly
- EpiQ
- Forest Pharmaceuticals, Hillside Hospital
- IMEDEX
- International Society for Bipolar Disorders
- Johnson Johnson
- MJ Consulting
- Medscape
- MBL Publishing, New York State
- NIMH
- Novartis
- PamLabs
- Pfizer
- PGx Health
- Physicians Postgraduate Press
- Ridge Diagnostics
- Schering-Plough
- SciMed
- ShireSUNY Buffalo
- Takeda/Lundbeck
- Targacept
- Teva Pharmaceuticals
- University of Texas Southwestern Dallas
- University of Wisconsin
- University of Pisa
- GlaxoSmithKline
- Wyeth
- Solvay
- Schering-Plough,
- Sanofi-Aventis
- Merck
Objective: Lithium salts, once the mainstay of therapy for bipolar disorder, have tolerability issues at a higher dosage that often limit adherence. The authors investigated the comparative effectiveness of more tolerable dosages of lithium as part of optimized personalized treatment (OPT). Method: The authors randomly assigned 283 bipolar disorder outpatients to 6 months of open, flexible, moderate dosages of lithium plus OPT or to 6 months of OPT alone. The primary outcome measures were the Clinical Global Impression Scale for Bipolar Disorder-Severity (CGI-BP-S) and necessary clinical adjustments (medication adjustments per month). Secondary outcome measures included mood symptoms and functioning. The authors also assessed sustained remission (defined as a CGI-BPS score <= 2 for 2 months) and treatment with second-generation antipsychotics. The authors hypothesized that lithium plus OPT would result in greater clinical improvement and fewer necessary clinical adjustments. Results: The authors observed no statistically significant advantage of lithium plus OPT on CGI-BP-S scores, necessary clinical adjustments, or proportion with sustained remission. Both groups had similar outcomes across secondary clinical and functional measures. Fewer patients in the lithium-plus-OPT group received second-generation antipsychotics compared with the OPT-only group (48.3% and 62.5%, respectively). Conclusions: In this pragmatic comparative effectiveness study, a moderate but tolerated dosage of lithium plus OPT conferred no symptomatic advantage when compared with OPT alone, but the lithium-plus-OPT group had less exposure to second-generation antipsychotics. Only about one-quarter of patients in both groups achieved sustained remission of symptoms. These findings highlight the persistent and chronic nature of bipolar disorder as well as the magnitude of unmet needs in its treatment. (Am J Psychiatry 2013; 170:102-110)
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