Quetiapine monotherapy in the treatment of patients with bipolar I or II depression and a rapid-cycling disease course: a randomized, double-blind, placebo-controlled study

• Published in: Bipolar disorders 2007-06, Vol.9 (4), p.413-425
• Main Authors: Vieta, E, Calabrese, JR, Goikolea, JM, Raines, S, Macfadden, W
• Format: Article
• Language: English
• Subjects: Adult; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; bipolar depression; Bipolar Disorder - diagnosis; Bipolar Disorder - drug therapy; Bipolar Disorder - psychology; Dibenzothiazepines - adverse effects; Dibenzothiazepines - therapeutic use; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Psychiatric Status Rating Scales; quetiapine; Quetiapine Fumarate; rapid-cycling; Secondary Prevention; Treatment Outcome
• ISSN: 1398-5647; 1399-5618
• DOI: 10.1111/j.1399-5618.2007.00479.x

Objectives:  To investigate the efficacy and tolerability of quetiapine monotherapy in patients with bipolar I or II disorder with a rapid‐cycling disease course. Methods:  Adult patients with a DSM‐IV diagnosis of bipolar disorder, most recent episode depressed, with a rapid‐cycling disease course from a previously completed multicenter trial randomized to 8 weeks of treatment with quetiapine 600 mg/day (n = 31), quetiapine 300 mg/day (n = 42), or placebo (n = 35) were included in this sub‐analysis. The primary efficacy variable was change from baseline to week 8 in Montgomery–Asberg Depression Rating Scale (MADRS) total score. Results:  Quetiapine (600 and 300 mg/day) provided significantly greater mean reductions from baseline to week 8 in the MADRS total score than placebo (−21.1, −20.7 versus −11.6, both p