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Completed

NCT Number: NCT03222570

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

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.

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal Psychotherapy for Depressed Adolescents

Behavioral

IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.

selective serotonin reuptake inhibitor

Drug

Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline

Usual Care

Other

Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI

Primary outcomes

  1. Children's Depression Rating Scale - Revised

    Time frame: 16 weeks

    Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome

Secondary outcomes

  1. Children's Global Assessment Scale

    Time frame: 16 weeks

    Measure of general psychosocial functioning Minimum score: 1 Maximum score: 100 A higher score indicates a better outcome

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2017
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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