A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
In this study, quetiapine is being tested for the possible treatment of bipolar I disorder with an acute depressive episode in children and adolescents.
We hypothesize that quetiapine will be more efficacious than placebo for the treatment of episodes of major depression associated with adolescent BP. Moreover, we hypothesize that quetiapine will be safe and well-tolerated compared with placebo for the treatment of depression associated with adolescent BP. Based on data from the BOLDER study and other studies of atypical antipsychotics in patients with bipolar depression (Calabrese et al., 2004, Macfadden et al., 2004, Tohen et al., 2004), which in general reveal effect sizes of approximately 0.5, a conservative sample size calculation, assuming power of .8, estimates we would need approximately 15 patients in each group to identify a statistically significant group difference in our main outcome measure, change form baseline to endpoint in the Children's Depression Rating Scale (Poznanski, 1979).
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder|
- Children's Depression Rating Scale (CDRS): Measure of efficacy will be a change in CDRS total scores from baseline endpoint.
- Secondary Efficacy Measures
- CDRS response rate: Defined by a > 50% decrease from baseline to endpoint in CDRS total score.
- Clinical Global Impression Improvement Scale BP Version (CGI-I BP) Improvement Score response rate: Defined by an endpoint CGI-I score of 1 or 2 (much or very much improved)
- Hamilton Anxiety Rating Scale (HAM-A): Measure of efficacy will be change from baseline to endpoint in HAM-A
- Proportion of patients who met criteria for treatment-emergent mania (YMRS score > 16 on two consecutive visits or at final assessment).
- Incidence of adverse events
- Incidence of EPS (as measured by change from baseline to endpoint in EPS rating scales)
- Change from baseline to endpoint in all laboratory measures and vital signs.
|Study Start Date:||October 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45267-0559|
|Principal Investigator:||Melissa DelBello, MD||University of Cincinnati and Cincinnati Children's Hospital|