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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition
Pediatric Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Screening Protocol [ Time Frame: Study Enrollment ] [ Designated as safety issue: No ]
    This protocol is a prescreening for other research studies.


Estimated Enrollment: 1000
Study Start Date: September 2001
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Detailed 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.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and Adolescents with symptoms of bipolar disorder

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592267

Contacts
Contact: Rebecca Grossman, BA 617-643-1432 rgrossman1@partners.org

Locations
United States, Massachusetts
Masschusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592267     History of Changes
Other Study ID Numbers: 2001-P-001247
Study First Received: December 28, 2007
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
pediatric
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014