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
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2001
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 28, 2007
CompletedFirst Posted
Study publicly available on registry
January 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 18, 2022
January 1, 2022
22.3 years
December 28, 2007
January 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Screening Protocol
This protocol is a prescreening for other research studies.
Study Enrollment
Study Arms (1)
1
Eligibility Criteria
Children and Adolescents with symptoms of bipolar disorder
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masschusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Biederman, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Study Record Dates
First Submitted
December 28, 2007
First Posted
January 14, 2008
Study Start
September 1, 2001
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
January 18, 2022
Record last verified: 2022-01