Greater Houston Area Pediatric Bipolar Registry
Part of paid clinical trials in Houston, Texas.
- Sponsor
- The University of Texas Health Science Center, Houston
- Study ID
- NCT06665984
- Status
- Recruiting
Conditions
- Pediatric Bipolar Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 17 Years
- Healthy Volunteers
- Accepted
Study Details
The purpose of this study is to perform a comprehensive research assessment of children and adolescents who meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for Bipolar Disorder (BD) , offspring of a parent with BD, and healthy controls (HC), to obtain blood samples and saliva samples from each subject to allow the evaluation for BD biomarkers and genetic information, to notify participants about future research studies they may qualify for , to recommend follow-up with an outpatient provider if needed and to use magnetic resonance imaging (MRI) (structural MRI and diffusion tensor imaging) to investigate brain structures and relevant pathways associated with mood and behavioral regulation, conversion from softer forms of the BD spectrum (BD-NOS) to harder forms (BD-I and BD-II) and possible early identification.
Key Dates
- Start date
- Dec 6, 2022
- Status verified
- Feb 2026
- Primary completion
- Dec 6, 2027
- Completion
- Dec 6, 2046
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Bipolar Patients
- Arm: Offspring of Bipolar Parents
- Arm: Healthy Control Subjects
Primary Outcome Measure
Positive Identification of Bipolar Disorder as Assessed by Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid 7.2) (child) [ Time Frame: baseline, annually until participant turns 25 years of age ]
Central Contacts
- Jair C Soares, M.D. PhD(713) 486-6663
- Courtney Vecera(713) 486-6663
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77479 |