Actively Recruiting

Age: 9Years - 19Years
All Genders
ID05427123

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

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

80

Participants Needed

4

Research Sites

25 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

Researchers are studying youth aged 9 to 19 years who have bipolar spectrum disorders (BSDs), including Bipolar I, Bipolar II, Cyclothymic Disorder, and Other Specified Bipolar Disorder. The study aims to accurately diagnose these conditions and identify factors such as mood instability and inflammatory markers that may predict clinical outcomes over a 12-month period. This research is conducted across four specialized US sites within The Childhood Bipolar Network (CBN), focusing on improving pediatric BSD diagnosis and treatment. Participants will undergo initial screening including a structured diagnostic interview and a baseline blood test to measure inflammation. Over the year, youth and their parents will participate in multiple follow-up visits involving interviews, rating scales, and questionnaires. Study psychiatrists will provide medication management guided by expert-developed protocols, while psychosocial treatments may also be offered based on clinical judgment and availability, but are not standardized across sites. During the study, youth will be regularly assessed using various psychiatric and behavioral rating scales at baseline, 6 months, and 12 months, including mood and quality of life measures. Parents will complete weekly online reports on their child's symptoms through the year. The study tracks medication use and psychosocial interventions while aiming to develop standardized clinical tools and treatment approaches for youth with BSD. Participation involves ongoing interviews, assessments, and monitoring over a full year.

CONDITIONS

Brief 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 aged 9 to 19 years
  • Diagnosed with Bipolar I, Bipolar II, Other Specified Bipolar Disorder, or Cyclothymic Disorder by study team
  • Able to read and communicate in English to participate in assessments and treatment
  • Has a caregiver available to participate regularly in assessment and treatment
  • Caregiver can read and communicate in English or has access to translation services
Not Eligible

You will not qualify if you...

  • Diagnosis of autism spectrum disorder
  • Substance or alcohol abuse with impairment within the past 3 months
  • Medical or psychiatric disorder that is life-threatening or requires immediate hospitalization
  • Evidence of recent sexual or physical abuse by caregivers
  • Evidence of recent intimate partner violence between caregivers responsible for care

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Intake

Duration - 1 day

Participants undergo initial assessments including blood draw, medical history review, diagnostic interview, and evaluations of mood symptoms and family functioning.

1 visit (in-person)

Monitoring

Duration - 12 months

Participants' symptoms and functioning are monitored weekly through parent online reports for up to 12 months.

Weekly parent online reporting

Follow-up

Duration - At 6 and 12 months

Participants complete follow-up assessments at 6 and 12 months to evaluate treatment response and update relevant measures.

2 follow-up visits (in-person or remote)

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

D

Danielle M Denenny, PhD

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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Published Research Related To This Trial

A Risk Calculator to Predict the Individual Risk of Conversion From Subthreshold Bipolar Symptoms to Bipolar Disorder I or II in Youth.

Boris Birmaher, John A Merranko, Tina R Goldstein...

https://pubmed.ncbi.nlm.nih.gov/30274650

The International Society for Bipolar Disorders Task Force report on pediatric bipolar disorder: Knowledge to date and directions for future research.

Benjamin I Goldstein, Boris Birmaher, Gabrielle A Carlson...

https://pubmed.ncbi.nlm.nih.gov/28944987

A psychometric analysis of the Positive and Negative Affect Schedule for Children-Parent Version in a school sample.

Chad Ebesutani, Kelsie Okamura, Charmaine Higa-McMillan...

https://pubmed.ncbi.nlm.nih.gov/21381834

Assessment of a Person-Level Risk Calculator to Predict New-Onset Bipolar Spectrum Disorder in Youth at Familial Risk.

Danella M Hafeman, John Merranko, Tina R Goldstein...

https://pubmed.ncbi.nlm.nih.gov/28678992