CTRI/2009/091/000696CompletedPhase 3
An 8-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 194
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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 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.
Investigators
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