An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

• ClinicalTrials.gov Identifier: NCT03222570
• Recruitment Status: Recruiting
• First Posted: July 19, 2017
• Last Update Posted: April 14, 2022
• Sponsor: University of Minnesota
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Depressive Disorder	Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; Drug: Selective Serotonin Reuptake Inhibitor; Other: Usual Care	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression
• Actual Study Start Date: February 26, 2018
• Estimated Primary Completion Date: June 1, 2023
• Estimated Study Completion Date: October 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: IPT-A - possible augment with addl IPT-A; Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed systematically over the course of therapy. If an adolescent demonstrates an insufficient response to IPT-A at one of these assessments, the dose of IPT-A will be increased by scheduling sessions twice per week for 4 weeks (16 sessions total).	Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; 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.
Experimental: IPT-A - possible augment with SSRI; Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed systematically over the course of therapy. If an adolescent demonstrates an insufficient response to IPT-A at one of these assessments, treatment will be augmented by adding a selective serotonin reuptake inhibitor (SSRI).	Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; 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.; Drug: Selective Serotonin Reuptake Inhibitor; Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline
Active Comparator: Usual Care; 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.	Other: Usual Care; 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

Outcome Measures

Primary Outcome Measures :

1. Severity of depressive symptoms (Children's Depression Rating Scale - Revised) [ Time Frame: 36 weeks ]

Secondary Outcome Measures :

1. Level of Interpersonal functioning (aggregate of Conflict Behavior Questionnaire, Inventory of Parent and Peer Attachment - Revised, Issues Checklist, and parent and adolescent coded interpersonal behaviors during a conflict negotiation task) [ Time Frame: 36 weeks ]
   Measures will be aggregated using latent factor analysis.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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] & Beck Depression Inventory-II [BDI-II])
• 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
• Females who are pregnant, breastfeeding, or having unprotected sexual intercourse, due to the possibility of randomization to treatment with an SSRI.

Contacts and Locations

Contacts

Contact: Meredith Gunlicks-Stoessel, Ph.D.; 612-273-9844; mgunlick@umn.edu

Locations

United States, Minnesota

Institute for Translational Research in Children's Mental Health; Recruiting

Minneapolis, Minnesota, United States, 55415

Contact: Jane Acierno 612-403-4172 acier006@umn.edu

Sponsors and Collaborators

University of Minnesota

National Institute of Mental Health (NIMH)

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03222570
• Other Study ID Numbers: PSYCH-2017-25767; R01MH113748 ( U.S. NIH Grant/Contract )
• First Posted: July 19, 2017
• Last Update Posted: April 14, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All data resulting from the proposed project will be shared via the National Database for Clinical Trials (NDCT).
• Supporting Materials: Study Protocol

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Depressive Disorder; Mood Disorders; Mental Disorders; Serotonin; Serotonin Uptake Inhibitors; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators