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A 12-Week Single-Blind Trial of Quetiapine for the Treatment of Mood Symptoms in Adolescents at High Risk for Developing Bipolar I Disorder
Melissa P. DelBello, M.D.; Caleb M. Adler, M.D.; Rachel M. Whitsel, B.S.; Kevin E. Stanford, M.P.H.; and Stephen M. Strakowski, M.D.
Objective: To investigate the effectiveness and tolerability of quetiapine for the treatment of adolescents at high risk for developing bipolar I disorder.
Method: Twenty adolescents (aged 12-18 years) with mood symptoms that did not meet DSM-IV-TR criteria for bipolar I disorder and who had at least one first-degree relative with bipolar I disorder were recruited from August 2003 to June 2005 to participate in a single-blind, 12-week prospective study of quetiapine. Subjects were diagnosed using the Washington University in St. Louis Kiddie Schedule of Affective Disorders and Schizophrenia and were symptomatic, defined by a Young Mania Rating Scale (YMRS) score >= 12 or a Childhood Depression Rating Scale-Revised Version (CDRS-R) score >= 28 at baseline. The primary effectiveness measure was an endpoint Clinical Global Impressions-Improvement scale (CGI-I) score <= 2 ("much" or "very much" improved). Secondary efficacy measures included change from baseline to endpoint in YMRS and CDRS-R scores.
Results: Mood disorder diagnoses in the adolescents consisted of bipolar disorder not otherwise specified (N = 11), dysthymia (N = 3), bipolar II disorder (N = 3), cyclothymia (N = 2), and major depressive disorder (N = 1). The majority of patients (N = 12, 60%) were non-responders to previous trials of psychotropic agents. Fifteen subjects (75%) completed all study visits. Eighty-seven percent of patients were responders (CGI-I <= 2) to quetiapine at week 12 (mean ± SD endpoint dose = 460 ± 88 mg/day). YMRS scores decreased from 18.1 ± 5.5 at baseline to 8.7 ± 7.9 at endpoint (p < .0001), and CDRS-R scores decreased from 38.2 ± 9.8 to 27.7 ± 9.3, (p = .0003). The most frequently reported adverse events were somnolence, headache, musculoskeletal pain, and dyspepsia. No subjects discontinued study participation due to adverse events.
Conclusion: Although these findings are limited by the small sample size and open-label treatment, the results suggest that quetiapine may be an effective treatment for mood symptoms in adolescents with a familial risk for developing bipolar I disorder.
(J Clin Psychiatry 2007;68:789-795)
Received Jan. 3, 2006; accepted Feb. 19, 2007. From the Division of Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio.
This study was supported by funding from the Stanley Medical Research Institute, Chevy Chase, Md., and AstraZeneca Pharmaceuticals LP, Wilmington, Del.
Presented in part at the annual meeting of the American College of Neuropsychopharmacology, Dec. 11-15, 2005, Waikoloa, Hawaii.
Dr. DelBello receives research support from or serves as a consultant or speaker for Abbott, AstraZeneca, Shire, Eli Lilly, Pfizer, Johnson & Johnson, and Repligen. Dr. Adler receives research support from or serves as a consultant or speaker for Abbott, AstraZeneca, Shire, Eli Lilly, Pfizer, Johnson & Johnson, and Repligen. Dr. Strakowski receives research support from or serves as a consultant or speaker for AstraZeneca, Bristol-Myers Squibb, Shire, Eli Lilly, Pfizer, Ortho-McNeil, Janssen, Forest, and Repligen. Ms. Whitsel and Mr. Stanford report no other financial affiliation or relationship relevant to the subject of this article.
Corresponding author and reprints: Melissa P. DelBello, M.D., Division of Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati College of Medicine, 231 Bethesda Ave., P.O. Box 670559, Cincinnati, OH 45267-0559 (e-mail: firstname.lastname@example.org).