Status:
COMPLETED
A Study of Quetiapine for the Treatment of Mood Disorders in Adolescents
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
AstraZeneca
Conditions:
Mood Disorders
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to obtain preliminary data regarding the effectiveness, tolerability, and safety of quetiapine therapy for adolescents who have a mood disorder and have at least ...
Detailed Description
Bipolar disorder is a common, life-long, progressive disease that typically begins in adolescence or early adulthood and is associated with significant morbidity and mortality (Lish et al., 1994). Fam...
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 a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) mood disorder (dysthymia, major depressive disorder, depressive disorder not otherwise specified, cyclothymic, bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified) as determined by the Washington University at St. Louis Kiddie Schedule of Affective Disorders and Schizophrenia (WASH-U K-SADS) (Geller et al., 2000).
- Patients must currently display symptoms of depression/dysthymia (Childhood Depression Rating Scale \> 35) or mania/hypomania (Young Mania Rating Scale \> 14).
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.
- Neurologic disorders including epilepsy, stroke, or severe head trauma.
- Clinically significant laboratory abnormalities on any of the following tests: complete blood count (CBC) with differential, electrolytes, BUN, creatinine, hepatic transaminases, thyroid stimulating hormone (TSH), and electrocardiogram (EKG).
- Mood symptoms due to a general medical condition or substance-induced mania (DSM-IV).
- Mental retardation (intelligence quotient \[IQ\] \< 70).
- History of hypersensitivity to or intolerance to 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 serious suicidal risk.
- 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.
- 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, or psychotic disorder not otherwise specified) as defined in the DSM-IV.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00221468
Start Date
June 1 2003
End Date
April 1 2006
Last Update
July 18 2012
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267