Children's Bipolar Network Treatment Trial I

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-19
SponsorUniversity of California, Los Angeles

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Medication or psychosocial treatment

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of California, Los Angeles

Lead sponsor

University of Pittsburgh

Collaborator

Virginia Commonwealth University

Collaborator

University of Colorado, Denver

Collaborator

Milken Institute

Collaborator

Baszucki Brain Research Fund

Collaborator