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RECRUITINGOBSERVATIONAL

Children's Bipolar Network Treatment Trial I

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

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.

Locations (4)

University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
Los Angeles, California, United States
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center
Aurora, Colorado, United States
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States