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A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder

NCT00232414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-12-10

No results posted yet for this 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).

Conditions

Interventions

DRUG

Quetiapine

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Melissa DelBello, MD · University of Cincinnati and Cincinnati Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00232414 on ClinicalTrials.gov