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NCT00232414 · ClinicalTrials.gov registry record · Phase 3
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
A Phase 3 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT00232414 is a Phase 3 study that has completed, run by University of Cincinnati. The registered enrollment target is 30 participants.
The verdict
NCT00232414, a Phase 3 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Quetiapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00232414
The ClinicalTrials.gov registry entry for NCT00232414 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Quetiapine is the first listed.
NCT00232414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00232414 about?
NCT00232414 is a clinical study titled "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 ...
What is the current status of trial NCT00232414?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2005-10. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00232414?
The interventions under investigation include: Quetiapine (DRUG).
Who is sponsoring clinical trial NCT00232414?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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