Recruiting

Bipolar NetworkChildren's Bipolar Network Treatment Trial I

Sponsor:

UCLA

Code:

NCT05427123

Conditions

Bipolar Disorder

Bipolar I Disorder

Bipolar II Disorder

Other Specified Bipolar and Related Disorder

Mood Instability

Eligibility Criteria

Sex: All

Age: 9 - 19

Healthy Volunteers: Not accepted

Interventions

Medication or psychosocial treatment

Study Details

Brief 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

Study ID

NCT05427123

Start date

Jul 1, 2022

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 9 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Youth with or at clinical high risk for Bipolar Spectrum Disorder

Youth included in the study will have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of Bipolar I or II, Cyclothymic Disorder, or Other Specified Bipolar Disorder (per Course and Outcome of Bipolar Youth study definition)

Interventions

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.

Primary outcome measure

Change in Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) Psychiatric Status Ratings [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
Change in Children's Affective Lability Scale (CALS), Child and Parent Report forms [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
Change in Conflict Behavior Questionnaire (CBQ) scores, Child and Parent Report forms [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
Kiddo-KINDL Quality of Life Questionnaire for Children, Child and Parent Reports forms [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]

Central Contacts and Locations

Central contacts

David J Miklowitz, PhD

(310) 267-2659 dmiklowitz@mednet.ucla.edu

Danielle M Denenny, PhD

(323) 475-8252 ddenenny@mednet.ucla.edu

Locations

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

Recruiting

Los Angeles, California, United States, 90024

Contacts

David J Miklowitz, PhD

310-267-2659 dmiklowitz@mednet.ucla.edu

Megan C Ichinose, PhD

(424) 229-1683 michinose@mednet.ucla.edu

Principal Investigator:

David J Miklowitz, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

medication
psychosocial
treatment
longitudinal
naturalistic
assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-02-05.