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Behavioral Intervention

SSRI + Interpersonal Therapy for Adolescent Depression

Phase 2
Recruiting
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights

Study Summary

This trial is studying two ways to treat adolescent depression, one with a common SSRI medication and one with a more intensive form of therapy.

Who is the study for?
This trial is for adolescents aged 12-18 with major depression or related disorders, who are experiencing significant symptoms and impairment in daily functioning. It's not for those at immediate suicide risk, pregnant or sexually active without contraception, have certain other mental health conditions, take psychiatric meds (except for ADHD), or don't speak English.Check my eligibility
What is being tested?
The study tests two adaptive treatment strategies for teen depression: one involves interpersonal psychotherapy with systematic symptom monitoring and an algorithm to adjust therapy if needed; the other is usual care. Some may also receive SSRIs or more intensive therapy based on their response.See study design
What are the potential side effects?
Potential side effects from SSRIs can include nausea, sleep issues, nervousness, dizziness, weight changes and sexual dysfunction. Psychotherapy doesn't typically cause physical side effects but can sometimes bring up uncomfortable emotions during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a form of depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: IPT-A - possible augment with addl IPT-AExperimental Treatment1 Intervention
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).
Group II: IPT-A - possible augment with SSRIExperimental Treatment2 Interventions
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).
Group III: Usual CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interpersonal Psychotherapy for Depressed Adolescents
2009
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,391 Previous Clinical Trials
1,552,944 Total Patients Enrolled
32 Trials studying Depression
5,543 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,812 Previous Clinical Trials
2,667,474 Total Patients Enrolled
674 Trials studying Depression
253,419 Patients Enrolled for Depression

Media Library

Interpersonal Psychotherapy for Depressed Adolescents (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03222570 — Phase 2
Depression Research Study Groups: IPT-A - possible augment with SSRI, IPT-A - possible augment with addl IPT-A, Usual Care
Depression Clinical Trial 2023: Interpersonal Psychotherapy for Depressed Adolescents Highlights & Side Effects. Trial Name: NCT03222570 — Phase 2
Interpersonal Psychotherapy for Depressed Adolescents (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03222570 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT03222570 — Phase 2
~3 spots leftby Aug 2024
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