Naturalistic treatment and follow-up for youth with bipolar spectrum disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.