An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Depressive Disorder Clinical Trial

Official title:

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03222570
• Other study ID #: PSYCH-2017-25767
• Secondary ID: R01MH113748
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2018
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: Meredith Gunlicks-Stoessel, Ph.D.
• Phone: 612-273-9844
• Email: mgunlick[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

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

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

Locations

Country	Name	City	State
United States	Institute for Translational Research in Children's Mental Health	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of depressive symptoms (Children's Depression Rating Scale - Revised)		36 weeks
Secondary	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)	Measures will be aggregated using latent factor analysis.	36 weeks