Actively Recruiting

Age: 9Years - 19Years
All Genders
NCT05427123

Children's Bipolar Network Treatment Trial I

Led by University of California, Los Angeles · Updated on 2026-02-05

80

Participants Needed

4

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

U

University of Pittsburgh

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Children's Bipolar Network Treatment Trial I

Who Can Participate

Age: 9Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 participate in treatment and assessments appropriate for ages 9 and up
  • Youth has a caregiver able to participate regularly in assessment and treatment
  • The participating caregiver can reliably read and communicate in English for consenting, assessment, and treatment unless translation services are regularly available
Not Eligible

You will not qualify if you...

  • Youth has a DSM-5 diagnosis of autism spectrum disorder
  • Youth has a DSM-5 diagnosis of substance or alcohol abuse with impairment within the past 3 months
  • Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency 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

AI-Screening

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Trial Site Locations

Total: 4 locations

1

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

Los Angeles, California, United States, 90024

Actively Recruiting

2

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

Aurora, Colorado, United States, 80045

Enrolling by Invitation

3

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

Pittsburgh, Pennsylvania, United States, 15213

Enrolling by Invitation

4

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States, 23298

Enrolling by Invitation

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Research Team

D

David J Miklowitz, PhD

CONTACT

D

Danielle M Denenny, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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