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

NCT00221468 | Completed Phase 3

• 1 other identifier: IRUSQUET0296
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 one parent with bipolar disorder (severe mood swings).

Conditions

Mood Disorders

Keywords

Adolescents

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Improvement (CGI)

  The Clinical Global Impression Improvement Score of \< 2 (much or very much improved) will be used to quantify the adolescent's change in overall severity of illness.

  12 weeks

Secondary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  12 weeks

Study Arms (1)

Quetiapine

EXPERIMENTAL

Patients will begin 100mg of quetiapine on day 1 and titrated to a maximum dose of 400mg by day 4, with flexible dosing to 600mg by day 28. The total duration of treatment will be 84 days (12 weeks).

Drug: quetiapine

Interventions

quetiapine DRUG

100mg of quetiapine on day 1 and titrated to a maximum dose of 400mg by day 4, with flexible dosing to 600mg by day 28. The total duration of treatment will be 84 days (12 weeks).

Also known as: Seroquel

Quetiapine

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 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Mood Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Melissa P DelBello, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2003
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: July 18, 2012

Record last verified: 2007-03

Locations

US (1)