drugset / Trial / NCT03222570

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

NCT03222570 ↗

RandomizedSequentialSingle-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.

Timeline

Start
2018-02-26
Primary completion
2024-04-28
Completion
2024-04-28

Outcome

Missed primary endpoint

registry analysis (superiority test); IPT-A Adaptive Treatment Strategy vs Usual Care; p = 0.76; NCT03222570 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Citalopram Small molecule — —
Subject Escitalopram Small molecule — —
Subject Fluoxetine Small molecule — —
Subject Fluvoxamine Unknown — —
Subject Sertraline Small molecule — —

Indications