Pediatric Bipolar Depression

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.

• The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.

• Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.

• Patients must be able to swallow the study medication tablets.

Exclusion Criteria:

• The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.

• Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.

• The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.

• Patients who in your doctors judgement pose a current suicidal or homicidal risk.