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. Identifier: NCT00592267
Recruitment Status : Recruiting
First Posted : January 14, 2008
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

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 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


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

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

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

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 identifier (NCT number): NCT00592267

Contact: Rebecca Wolenski 617-643-6617
Contact: Alexa Pulli, BS 617-726-4651

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

Additional Information:
Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital Identifier: NCT00592267     History of Changes
Other Study ID Numbers: 2001-P-001247
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

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

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