A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT00232414|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 10, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder||Drug: Quetiapine||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232414
|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|