Pediatric Bipolar Disorder Clinical Trial
Official title:
A Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
NCT number | NCT00592267 |
Other study ID # | 2001-P-001247 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2001 |
Est. completion date | December 2023 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Masschusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Screening Protocol | This protocol is a prescreening for other research studies. | Study Enrollment |
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