Naturalistic treatment and follow-up for youth with bipolar spectrum disorders
A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder
This study looks at young people aged 9 to 19 with bipolar spectrum disorders to see how well they do over a year while receiving standard treatments and tracking their progress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 9 Years to 19 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Trial ID | NCT05427123 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on youth aged 9 to 19 diagnosed with bipolar spectrum disorders across four US sites. It aims to reliably diagnose these youth and examine predictors of clinical outcomes over a 12-month period. Participants will undergo a structured diagnostic interview and a blood draw to measure inflammatory markers, followed by multiple follow-up visits involving interviews and questionnaires. The study will track medication management and psychosocial treatments as per established guidelines.
Who should consider this trial
Good fit: Ideal candidates are youth aged 9 to 19 diagnosed with bipolar disorder or related conditions who can participate in assessments with their caregivers.
Not a fit: Patients with autism spectrum disorder or those with recent substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for youth with bipolar spectrum disorders.
How similar studies have performed: Other studies have shown success in similar approaches, particularly in optimizing treatments for pediatric bipolar disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 3 other locations
- University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP) — Los Angeles, California, United States (Recruiting)
- University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center — Aurora, Colorado, United States (Enrolling_by_invitation)
- University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS) — Pittsburgh, Pennsylvania, United States (Enrolling_by_invitation)
- Virginia Commonwealth University Medical Center — Richmond, Virginia, United States (Enrolling_by_invitation)
Study contacts
- Principal investigator: David J Miklowitz, PhD — University of California, Los Angeles
- Study coordinator: David J Miklowitz, PhD
- Email: dmiklowitz@mednet.ucla.edu
- Phone: (310) 267-2659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.