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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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 one parent with bipolar disorder (severe mood swings).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

To be included in this study, subjects must meet the following criteria:

1. Male or female patients, 12-18 years of age.

2. Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).

3. 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.

4. 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).

5. Patients must currently display symptoms of depression/dysthymia (Childhood Depression Rating Scale > 35) or mania/hypomania (Young Mania Rating Scale > 14).

Exclusion Criteria:

Patients will be excluded from the protocol for any of the following reasons:

1. Female patients who are either pregnant or lactating.

2. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic, or other systemic medical conditions.

3. Neurologic disorders including epilepsy, stroke, or severe head trauma.

4. 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).

5. Mood symptoms due to a general medical condition or substance-induced mania (DSM-IV).

6. Mental retardation (intelligence quotient [IQ] < 70).

7. History of hypersensitivity to or intolerance to quetiapine.

8. Prior history of quetiapine non-response.

9. DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.

10. Judged clinically to be at serious suicidal risk.

11. Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry.

12. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.

13. Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.

14. 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.