Status:
COMPLETED
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
AstraZeneca
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
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 ef...
Detailed Description
This is a double-blind, randomized 56-day treatment trial of quetiapine vs. placebo for the treatment of bipolar adolescents with acute depression. Randomization will be stratified by sex, the presenc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
- Patient who were treated with carbamazepine at any point during the month prior to screening.
- Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
- Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.
- Subjects who are not fluent in English.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00232414
Start Date
October 1 2005
End Date
December 1 2007
Last Update
December 10 2013
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559