Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
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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 |
- 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 |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00592267
| Contact: Leah Feinberg, BS | 617-726-4651 | lkfeinberg@mgh.harvard.edu |
| United States, Massachusetts | |
| Masschusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| 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: | November 5, 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 Mental Disorders Mood Disorders |
ClinicalTrials.gov processed this record on March 03, 2015