A Study of Quetiapine for the Treatment of Mood Disorders in Adolescents

Completed · Phase 3

Conditions studied: Mood Disorders

In brief

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 one parent with bipolar disorder (severe mood swings).

Key facts

Study ID

NCT00221468

Run by

University of Cincinnati

People needed

20

Starts

2003-06-01

Expected to finish

2006-04-01

Last updated by the study team

2012-07-18

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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 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).

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.
• 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.

Where it is running

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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