MedPath

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Phase 2
Completed
Conditions
Depressive Disorder
Registration Number
NCT03222570
Lead Sponsor
University of Minnesota
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> - Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent<br> Depressive Disorder, or Depressive Disorder NEC<br><br> - Current significant depressive symptoms (based on Children's Depression Rating Scale<br> - Revised [CDRS-R] & Beck Depression Inventory-II [BDI-II])<br><br> - Current impairment in psychosocial functioning (based on Children's Global<br> Assessment Scale [CGAS])<br><br>Exclusion Criteria:<br><br> - Non English-speaking<br><br> - Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use<br> disorder, autism spectrum disorder, or intellectual disability disorder.<br><br> - Adolescents who are actively suicidal with a plan and/or intent who are assessed to<br> need a higher level of care than outpatient treatment due to safety risk will be<br> referred for appropriate level of stabilization. Once stabilized, the adolescent can<br> be re-evaluated for eligibility to participate in the study.<br><br> - Currently taking medication for a psychiatric diagnosis other than ADHD<br><br> - Females who are pregnant, breastfeeding, or having unprotected sexual intercourse,<br> due to the possibility of randomization to treatment with an SSRI.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of depressive symptoms (Children's Depression Rating Scale - Revised)
Secondary Outcome Measures
NameTimeMethod
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)
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