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

NCT00232414 | Completed Phase 3 DMC

• 1 other identifier: IRUSQUET0384
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Bipolar I Disorder

Keywords

bipolar; with acute depressive episode

Outcome Measures

Primary Outcomes (1)

• Children's Depression Rating Scale (CDRS): Measure of efficacy will be a change in CDRS total scores from baseline endpoint.

Secondary Outcomes (9)

• 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

• Safety

Interventions

Quetiapine DRUG

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To be included in this study, subjects must meet the following criteria:
• Male or female patients, 12-18 years of age.
• Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
• Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
• Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) BP, type I and currently display an acute depressive episode as determined by K-SADS (Geller et al 2000).
• Patients must have a baseline (day 0) CDRS score of at least 40.
• Subjects should be fluent in English.

You may not qualify if:

• Patients will be excluded from the protocol for any of the following reasons:
• Female patients who are either pregnant or lactating.
• Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
• Any history of current or past diabetes that was treated with pharmacological intervention.
• Neurological disorders including epilepsy, stroke, or severe head trauma.
• Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, thyroid indices and EKG.
• Depression due to a general medical condition or substance-induced depression (DSM-IV).
• Mental retardation (IQ \<70).
• YMRS score of \> 12.
• History of hypersensitivity to or intolerance of quetiapine.
• Prior history of quetiapine non-response.
• DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
• Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline CDRS suicide score of \> 3).
• Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
• Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.

Sponsors & Collaborators

• University of Cincinnati: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related Publications (1)

• Danielyan A, Patino LR, Benanzer T, Blom TJ, Welge JA, Chang KD, Adler CM, DelBello MP. Cognitive, Family, and Quality-of-Life Characteristics of Youth with Depression Associated with Bipolar Disorder. J Child Adolesc Psychopharmacol. 2023 Aug;33(6):225-231. doi: 10.1089/cap.2023.0002.

  PMID: 37590017 DERIVED

MeSH Terms

Interventions

Quetiapine Fumarate

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Melissa DelBello, MD

  University of Cincinnati and Cincinnati Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (1)