A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
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, assessing, and treating BSDs in youth. The primary aims of this study are to (1) identify and reliably diagnose youth (ages 9 to 19 yrs) with full bipolar disorder (BD) and BSDs, and (2) examine predictors (e.g., mood instability, inflammatory marker C-reactive protein) of clinical outcome over a 12 month period. Participating youth will initially complete a screening that includes a structured diagnostic interview and a baseline blood draw to measure inflammatory processes. Youth with BSD and parents (80 families) will be asked to participate in multiple follow up research visits with interviews, rating instruments, and questionnaires. Per established CBN guidelines, study psychiatrists will provide and track medication management and sites will also track psychosocial treatments. This study ultimately aims to further understanding of best practice pediatric BSD psychiatric and psychosocial treatments and development of a standardized and validated set of clinical tools for patient assessment, diagnosis, and tracking.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
RECRUITING
Los Angeles
Colorado
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center
ENROLLING_BY_INVITATION
Aurora
Pennsylvania
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)
ENROLLING_BY_INVITATION
Pittsburgh
Virginia
Virginia Commonwealth University Medical Center
ENROLLING_BY_INVITATION
Richmond
Contact Information
Primary
David J Miklowitz, PhD
dmiklowitz@mednet.ucla.edu
(310) 267-2659
Backup
Danielle M Denenny, PhD
ddenenny@mednet.ucla.edu
(323) 475-8252
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 80
Treatments
Youth with or at clinical high risk for Bipolar Spectrum Disorder
Youth included in the study will have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of Bipolar I or II, Cyclothymic Disorder, or Other Specified Bipolar Disorder (per Course and Outcome of Bipolar Youth study definition)
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: Virginia Commonwealth University, Baszucki Brain Research Fund, University of Pittsburgh, University of Colorado, Denver, Milken Institute

This content was sourced from clinicaltrials.gov