Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder

This study is currently recruiting participants.
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592267
First received: December 28, 2007
Last updated: October 21, 2013
Last verified: October 2013

December 28, 2007
October 21, 2013
September 2001
December 2020   (final data collection date for primary outcome measure)
Screening Protocol [ Time Frame: Study Enrollment ] [ Designated as safety issue: No ]
This protocol is a prescreening for other research studies.
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Complete list of historical versions of study NCT00592267 on ClinicalTrials.gov Archive Site
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Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
A Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Children and Adolescents with symptoms of bipolar disorder

Pediatric Bipolar Disorder
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1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar disorder.
  • Subject and parent/ legal guardian must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
  • Subjects and their parent/ legal representative must be considered reliable.
  • Each subject and his/her parent or authorized legal representative must understand the nature of the study. The subject's parent or authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
  • One parent/ legal guardian must be able to accompany the subject to the clinic at each visit.

Exclusion Criteria:

  • Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  • Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
  • Mental retardation
Both
4 Years to 17 Years
No
Contact: Rebecca Grossman, BA 617-643-1432 rgrossman1@partners.org
United States
 
NCT00592267
2001-P-001247
No
Joseph Biederman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP