© 2004 The Royal College of Psychiatrists
Relapse prevention in bipolar I disorder: 18-month comparison of olanzapine plus mood stabiliser v. mood stabiliser alone
Lilly Research Laboratories, Indianapolis, Indiana, and Harvard Medical School/McLean Hospital, Belmont, Massachusetts
Western Psychiatric Institute and Clinic, University of Pittsburgh, Pennsylvania
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas
Lilly Research Laboratories, Indianapolis, Indiana
Mood and Anxiety Disorders Program, National Institute of Mental Health, Bethesda, Maryland
Department of Psychiatry, University of Texas Health Science Center, San Antonio, Texas
Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
Department of Psychiatry, Harvard Medical School/Cambridge Hospital, Cambridge, Massachusetts
Lilly Research Laboratories, Indianapolis, Indiana
Department of Psychiatry, Case Western Reserve University, Cleveland, Ohio, USA
Correspondence: Dr M.Tohen, Lilly Research Laboratories, Indianapolis IN46285, USA. Tel: (317) 277 9585; fax: (317) 433 5101; e-mail: m.tohen{at}lilly.com
Declaration of interest M.T., R.W.B., P.D.F., A.R.E. and R.C.R. are stockholders in Eli Lilly & Company, the sponsor of this study.
Background Few controlled studies have examined the use of atypical antipsychotic drugs for prevention of relapse in patients with bipolar I disorder.
Aims To evaluate whether olanzapine plus either lithium or valproate reduces the rate of relapse, compared with lithium or valproate alone.
Method Patients achieving syndromic remission after 6 weeks’treatment with olanzapine plus either lithium (0.6–1.2 mmol/l) or valproate (50–125 µg/ml) received lithium or valproate plus either olanzapine 5–20 mg/day (combination therapy) or placebo (monotherapy), and were followed in a double-masked trial for 18 months.
Results The treatment difference in time to relapse into either mania or depression was not significant for syndromic relapse (median time to relapse: combination therapy 94 days, monotherapy 40.5 days; P=0.742), but was significant for symptomatic relapse (combination therapy 163 days, monotherapy 42 days; P=0.023).
Conclusions Patients taking olanzapine added to lithium or valproate experienced sustained symptomatic remission, but not syndromic remission, for longer than those receiving lithium or valproate monotherapy.
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BJP 2004 184: 287-a15-298-a15.[Full Text]
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