Phase 2
N=90
An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression
Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03222570 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Children's Depression Rating Scale - Revised — 36.0; 37.5 score on a scale — p=0.76
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interpersonal Psychotherapy for Depressed Adolescents (Behavioral); Selective Serotonin Reuptake Inhibitor (Drug); Usual Care (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Depression Rating Scale - Revised |
36.0; 37.5 | 0.76 |
| SECONDARY Children's Global Assessment Scale |
61.8; 63.3 | 0.32 |
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.
Eligibility Criteria
Inclusion Criteria
- Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC
- Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised [CDRS-R])
- Current impairment in psychosocial functioning (based on Children's Global Assessment Scale [CGAS])
Exclusion Criteria
- Non English-speaking
- Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder.
- Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study.
- Currently taking medication for a psychiatric diagnosis other than ADHD
Data sourced from ClinicalTrials.gov (NCT03222570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.