Clinical trial NCT03222570: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-07-19
Enrollment: 91
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Severity of depressive symptoms (Children's Depression Rating Scale - Revised)
timeFrame: 36 weeks
Secondary outcomes:
measure: 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)
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Institute for Translational Research in Children's Mental Health
state: Minnesota
Study officials:
References: