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Recruiting
NCT05609916
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Conditions: Cognitive Behavioral Therapy, Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder in Children, Obsessive-Compulsive Disorder in Adolescence
Sex: All
Ages: 7 Years – 17 Years
Phase: NA
Enrollment: 200
Sponsor: Baylor College of Medicine
Location: United States
Summary
The purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.
Eligibility Criteria
Inclusion Criteria:The child is between the ages of 7 to 17 at enrollment with a primary diagnosis of OCD of > 6 months duration based on the Kiddie Schedule for Affective Disorders and Schizophrenia Lifetime Version for DSM-5 (KSADS-PL) and have a CY-BOCS ≥ 16.The child is on stable and maximally tolerated SRI medication (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, citalopram, escitalopram) for ≥12 weeks given that they are persistently and moderately symptomatic.
Paroxetine is exclusionary due to safety concerns.Both the child and parent participating in the study are English speaking.Both the child and their parent participating in the study reside in Texas.Exclusion Criteria:The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.The child is receiving concurrent psychotherapy for OCD.Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
Source: ClinicalTrials.gov (NCT05609916). StuddyBuddy aggregates publicly available trial information.