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Clinical Trial Summary

The objective of this protocol is to establish a comprehensive screening process for the evaluation of eligibility for entry in a clinical trial program for children and adolescents with bipolar disorder.


Clinical Trial Description

To address the urgent therapeutic needs of children and adolescents ages 4-17 with pediatric bipolar disorder, we have designed a series of clinical trials aimed at evaluating critical components of the treatment needs of this under-served and under-researched population. This approach will allow us to provide a full complement of clinical trials that will meet the most pressing needs of the bipolar children and adolescents and their families who are currently awaiting treatment. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs makes it very difficult to ask subjects to sign a specific clinical protocol without obtaining additional clinical information. Because of this we are proposing potential subjects to consent to undergo an in-depth clinical assessment that will allow subjects to be screened by a clinician for eligibility to a diverse clinical trials program available to them. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00592267
Study type Observational
Source Massachusetts General Hospital
Contact Rebecca Wolenski
Phone 617-643-6617
Email rwolenski@partners.org
Status Recruiting
Phase
Start date September 2001
Completion date December 2023

See also
  Status Clinical Trial Phase
Terminated NCT00592358 - Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder Phase 4
Completed NCT00586222 - Omega 3 Fatty Acid Trial Phase 1
Terminated NCT00592683 - Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents Phase 4
Terminated NCT00592852 - Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder Phase 4
Recruiting NCT01954680 - Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study Phase 1