Children's Bipolar Network Treatment Trial I

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.

Conditions

• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder
• Other Specified Bipolar and Related Disorder
• Mood Instability
• Child Mental Disorder
• Adolescent - Emotional Problem

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.

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Milken Institute

  collaborator OTHER

• Baszucki Brain Research Fund

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• David J Miklowitz, PhD · University of California, Los Angeles

Eligibility

Min Age

9 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2027-01-01

Completion

2027-07-01

Countries

• United States

Study Locations