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An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Primary Purpose

Depressive Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Depressed Adolescents
Selective Serotonin Reuptake Inhibitor
Usual Care
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute for Translational Research in Children's Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

IPT-A - possible augment with addl IPT-A

IPT-A - possible augment with SSRI

Usual Care

Arm Description

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).

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).

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.

Outcomes

Primary Outcome Measures

Severity of depressive symptoms (Children's Depression Rating Scale - Revised)

Secondary Outcome Measures

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.

Full Information

First Posted
July 13, 2017
Last Updated
July 12, 2023
Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03222570
Brief Title
An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression
Official Title
An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPT-A - possible augment with addl IPT-A
Arm Type
Experimental
Arm Description
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).
Arm Title
IPT-A - possible augment with SSRI
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Depressed Adolescents
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Selective Serotonin Reuptake Inhibitor
Intervention Description
Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Severity of depressive symptoms (Children's Depression Rating Scale - Revised)
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
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)
Description
Measures will be aggregated using latent factor analysis.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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] & 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith Gunlicks-Stoessel, Ph.D.
Phone
612-273-9844
Email
mgunlick@umn.edu
Facility Information:
Facility Name
Institute for Translational Research in Children's Mental Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Acierno
Phone
612-403-4172
Email
acier006@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data resulting from the proposed project will be shared via the National Database for Clinical Trials (NDCT).

Learn more about this trial

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

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