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RECRUITING
NCT05427123

Children's Bipolar Network Treatment Trial I

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

9 Years - 19 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2022-07-01

Completion Date

2027-07-01

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

OTHER

Medication or psychosocial treatment

Youth included in this naturalistic study will be offered medication management from study psychiatrists. The study's Network Oversight Committee, consisting of PI psychiatrists and consultants, has created guidelines on best practice medications, dosing, and adjustments for the study. The Network Oversight Committee will also offer ongoing consultation to study psychiatrists. The treating physician will take these guidelines and recommendations under consideration but will use clinical judgment and have the final say, in consultation with the parents and child, as to what treatments are prescribed. While psychosocial interventions are of interest as a predictor of outcomes, no universal psychotherapy or other psychosocial treatment will be provided by sites. There is no limitation on participant enrollment in psychosocial treatments. Investigators and their clinical partners may offer these interventions based on clinical judgment and availability.

Locations (4)

University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)

Los Angeles, California, United States

University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center

Aurora, Colorado, United States

University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)

Pittsburgh, Pennsylvania, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States