Last updated: April 9, 2025
Sponsor: Centre for Addiction and Mental Health
Overall Status: Active - Recruiting
Phase
N/A
Condition
Bipolar Disorder
Mood Disorders
Treatment
Dialectical behavioral therapy
Clinical Study ID
NCT05153382
049/2021
Ages 13-23 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- English-speaking; 2) Age 13 years, 0 months to 23 years, 11 months; 3) Meetdiagnostic criteria for BD by KSADS-PL (< 20 years of age) or SCID-5-RV (> 20 yearsof age) OR have a biological parent/sibling with BD (type I or II) confirmed viaKSADS-PL or SCID-5-RV; 4) If BD-I, taking ≥1 mood stabilizing medication (i.e.,antimanic anticonvulsant, antipsychotic, and/or lithium); 5) Followed by apsychiatrist who provides ongoing care; 6a) At least 1 suicide attempt in the pastyear (actual, interrupted, and/or aborted as measured by the C-SSRS) OR at least 1preparatory act or behavior in the past year as measured by the C-SSRS ORnon-suicidal self-injurious (NSSI) behaviors in the past 3 months (as measured bythe C-SSRS) -OR- 6b) Meet youth threshold for at least 2 impulsive behaviorcategories on question #4 from the SIDP-IV or 1 category is identified as severe (through case discussion that will focus on level of risk, persistence, andimpairment); 7) Able and willing to give informed consent/assent to participate.
Exclusion
Exclusion Criteria:
- Evidence of mental retardation, moderate to severe autism spectrum disorder, ororganic central nervous system disorder by the K-SADS-PL (< 20 years of age), parentreport, medical history, or school records that would interfere with activeparticipation in DBT; 2) A life-threatening medical condition requiring immediatetreatment; 3) Current victim of sexual or physical abuse; 4) Current substance usedisorder other than mild cannabis or alcohol use disorder.
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Dialectical behavioral therapy
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
November 30, 2026
Study Description
Connect with a study center
Centre for Addiction and Mental Health
Toronto, Ontario M6J 1H4
CanadaActive - Recruiting


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