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

Authors


  • EV has received research grants from AstraZeneca, Bristol-Myers Squibb, Eli Lilly & Co., GlaxoSmithKline, Janssen-Cilag, Novartis, and Pfizer; is a speaker or is involved in advisory boards for AstraZeneca, Bristol-Myers Squibb, Eli Lilly & Co., GlaxoSmithKline, Janssen-Cilag, Organon, Pfizer, Sanofi, and Servier; and is a consultant to AstraZeneca, Bial, Bristol-Myers Squibb, Eli Lily & Co., Janssen-Cilag, Lundbeck, Merck Sharp & Dohme, Novartis, Organon, Pfizer, Sanofi, Servier, and UCB. JRC has received research grants from Abbott, AstraZeneca, The Cleveland Foundation, GlaxoSmithKline, Janssen, NARSAD, Eli Lilly & Co., Repligen and The Stanley Medical Research Institute, and federal funding from the Department of Defense, Health Resources Services Administration and NIMH; and is a consultant or is involved in advisory boards for Abbott, AstraZeneca, Bristol-Myers Squibb, France Foundation, GlaxoSmithKline, Janssen, Johnson & Johnson Pharmaceutical Research & Development, and Solvay/Wyeth. JMG has received research grants from AstraZeneca and GlaxoSmithKline and is a consultant to Merck Sharp & Dohme. SR is an employee of AstraZeneca Pharmaceuticals LP. WM is a former employee of AstraZeneca Pharmaceuticals LP.

Corresponding author: Eduard Vieta, MD, PhD, IDIBAPS, University of Barcelona, Bipolar Disorders Program, Hospital Clinic, Villarroel 170/ Rossello 140, 08036 Barcelona, Spain.
Fax: +34 93 2275477; e-mail: evieta@clinic.ub.es

Abstract

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 < 0.001) in this patient population. Effect sizes in patients with a rapid-cycling disease course were 1.2 (600 mg/day) and 1.1 (300 mg/day) and were similar for bipolar I (0.98 and 1.22) and bipolar II (1.45 and 0.97) sub-groups. Significant improvements were also noted on the Clinical Global Impression, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Pittsburgh Sleep Quality Index, and Quality of Life Enjoyment and Satisfaction Questionnaire scales. Quetiapine was generally well tolerated with moderate increases in weight and extrapyramidal side effects compared to placebo. The incidence of treatment-emergent mania was similar to placebo.

Conclusions:  Quetiapine monotherapy (600 or 300 mg/day) is clinically effective and well tolerated in the short-term treatment of depressive episodes in patients with bipolar I or II disorder who have a rapid-cycling disease course.

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