Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00592267|
Recruitment Status : Recruiting
First Posted : January 14, 2008
Last Update Posted : March 8, 2018
|Condition or disease|
|Pediatric Bipolar Disorder|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||A Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder|
|Study Start Date :||September 2001|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Screening Protocol [ Time Frame: Study Enrollment ]This protocol is a prescreening for other research studies.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592267
|Contact: Rebecca Wolenskiemail@example.com|
|Contact: Alexa Pulli, BSfirstname.lastname@example.org|
|United States, Massachusetts|
|Masschusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Joseph Biederman, MD||Massachusetts General Hospital|