Status:
TERMINATED
Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
University of Alberta
Conditions:
Depression in Adolescence
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years (n=452) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression will be rando...
Detailed Description
Goal: To test the efficacy of pharmacogenetic-guided antidepressant prescribing for adolescents with depression. Background: For an adolescent with moderate to severe depression, antidepressant medic...
Eligibility Criteria
Inclusion
- Age 12-17
- Depression as the primary concern, confirmed by the treating physician
- QIDS-A17 score greater than or equal to 11 indicating moderate-to-severe symptoms
- Intention to start a new SSRI
- English fluency
Exclusion
- Co-occurring psychosis, bipolar disorder, eating disorder, autism spectrum disorder, fetal alcohol spectrum disorder, or intellectual disability
- A score of 2 or 3 on suicide item 13 of the QIDS-A17
- High-risk alcohol or substance use (excluding cannabis and tobacco) as indicated by a score of monthly or more on the S2BI
- History of non-response to 3 or more SSRI medications as confirmed by the treating physician
- Brain stimulation-based therapy initiated within 8 weeks of referral, or plans to initiate/change brain stimulation during study participation
- History of liver or hematopoietic cell transplant
- History of CYP2B6, CYP2C19, or CYP2D6 testing
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05965401
Start Date
October 25 2023
End Date
May 2 2025
Last Update
May 20 2025
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1