Children's Bipolar Network Treatment Trial I

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05427123
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
9 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Medication or psychosocial treatment — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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)

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. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)Los AngelesCalifornia90024
David J Miklowitz, PhD
[email protected]
310-267-2659
Megan C Ichinose, PhD
[email protected]
(424) 229-1683
David J Miklowitz, PhD (PRINCIPAL_INVESTIGATOR)
Danielle M Denenny, PhD (SUB_INVESTIGATOR)
Jennifer M Gamarra, PhD (SUB_INVESTIGATOR)
Elizabeth A Horstmann, MD (SUB_INVESTIGATOR)
Megan C Ichinose, PhD (SUB_INVESTIGATOR)
Sarah E Marvin, PhD (SUB_INVESTIGATOR)
Robert L Suddath, MD (SUB_INVESTIGATOR)
Patricia D Walshaw (SUB_INVESTIGATOR)
Marc J Weintraub, PhD (SUB_INVESTIGATOR)
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression CenterAuroraColorado80045-
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)PittsburghPennsylvania15213-
Virginia Commonwealth University Medical CenterRichmondVirginia23298-

Find similar trials in Los Angeles, CA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)· Los Angeles, CAUniversity of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center· Aurora, COUniversity of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)· Pittsburgh, PAVirginia Commonwealth University Medical Center· Richmond, VA

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