Objective: To evaluate the efficacy and safety of quetiapine monotherapy in children and adolescents with mania associated with bipolar I disorder.
Method: Patients aged 10 to 17 years, with a DSM-IV-TR diagnosis of a manic episode associated with bipolar I disorder and Young Mania Rating Scale (YMRS) total score ≥ 20 were randomized to 3 weeks of quetiapine (400 or 600 mg/d) or placebo. The primary efficacy measure was change in YMRS total score. The study was conducted at 34 centers in the United States between August 2004 and July 2006.
Results: The intent-to-treat population included 277 patients. Least squares mean change in YMRS score from baseline to end point by mixed-model, repeated-measures analysis was –14.25, –15.60, and –9.04 for quetiapine 400 mg/d, quetiapine 600 mg/d, and placebo, respectively (P < .001, each quetiapine dose vs placebo). Significant improvement in YMRS score versus placebo was first observed at day 4 (P = .015) with quetiapine 400 mg/d and day 7 (P < .001) with quetiapine 600 mg/d. Mean changes in body weight at day 21 (observed cases) were 1.7 kg for both quetiapine doses and 0.4 kg for placebo. Numerically larger mean increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides were observed with quetiapine than placebo. Adverse events associated with quetiapine were mostly mild to moderate in intensity.
Conclusions: In this 3-week study, quetiapine was significantly more effective than placebo in improving manic symptoms in youth with mania associated with bipolar disorder. Treatment was generally well tolerated and adverse events were broadly consistent with the known profile of quetiapine in adults with bipolar disorder.
Trial Registration: ClinicalTrials.gov identifier: NCT00090311
J Clin Psychiatry 2013;74(1):e100–e109
© Copyright 2013 Physicians Postgraduate Press, Inc.
Submitted: September 27, 2011; accepted September 20, 2012 (doi:10.4088/JCP.11m07424).
Corresponding author: Sanjeev Pathak, MD, Clinical Research-Neuroscience, AstraZeneca Pharmaceuticals LP, B3C-421, 1800 Concord Pike, PO Box 15437-5437, Wilmington, DE 19850 (email@example.com).