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NCT05427123Recruiting

Children's Bipolar Network Treatment Trial I

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
18 Mar 2022
Start date
1 Jul 2022
Primary completion date
1 Jan 2027
Lead sponsor
University of California, Los Angeles
NCT number
NCT05427123

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 1 Jul 2022 to the primary completion date, 1 Jan 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 9 years to 19 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center
Coordinator of this site? Confirm its status
AuroraUnited StatesEnrolling by invitation
University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)
Coordinator of this site? Confirm its status
PittsburghUnited StatesEnrolling by invitation
Virginia Commonwealth University Medical Center
Coordinator of this site? Confirm its status
RichmondUnited StatesEnrolling by invitation

This page is information, not medical advice. Discuss any trial with your doctor.