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

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ClinicalTrials.gov Identifier: NCT00592267
Recruitment Status : Recruiting
First Posted : January 14, 2008
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Pediatric Bipolar Disorder

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.


Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1


Outcome Measures

Primary Outcome Measures :
  1. Screening Protocol [ Time Frame: Study Enrollment ]
    This protocol is a prescreening for other research studies.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592267


Contacts
Contact: Rebecca Wolenski 617-643-6617 rwolenski@partners.org
Contact: Alexa Pulli, BS 617-726-4651 apulli@mgh.harvard.edu

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:
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
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
pediatric
bipolar disorder

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders