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).
- Conditions
- Health Condition 1: null- Children and Adolescent Subjects With Bipolar Depression
- Registration Number
- CTRI/2009/091/000696
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 194
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.
- 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 cannot 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method