Status:
RECRUITING
Children's Bipolar Network Treatment Trial I
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
University of Pittsburgh
Virginia Commonwealth University
Conditions:
Bipolar Disorder
Bipolar I Disorder
Eligibility:
All Genders
9-19 years
Brief Summary
This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN). CBN sites have expertise in diagnosing...
Detailed Description
Study Background and Significance Cross-site research networks for specific childhood diseases have led to important treatment advances, such as guidance of optimizing treatments for individual patie...
Eligibility Criteria
Inclusion
- Youth 9-19 years old
- Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening
- Youth is able to read and communicate in English to the degree necessary to be able to assent and participate (with help) in their treatment and assessments appropriate for ages 9 and up
- Youth has a caregiver able to participate in ongoing basis in assessment and treatment
- The participating caregiver can reliably read and communicate in English for purposes of study consenting, assessment, and treatment, unless preferred language translation services are regularly available.
Exclusion
- Youth has DSM-5 diagnosis of autism spectrum disorder
- Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos.
- Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment
- Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers
- Evidence of recent intimate partner violence between caregivers responsible for the youth's care
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05427123
Start Date
July 1 2022
End Date
July 1 2027
Last Update
April 1 2025
Active Locations (4)
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1
University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
Los Angeles, California, United States, 90024
2
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center
Aurora, Colorado, United States, 80045
3
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)
Pittsburgh, Pennsylvania, United States, 15213
4
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298