CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Recruiting · NCT05609916 · Interventional (participants receive a specific treatment) · Lead sponsor: Baylor College of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive Behavioral Therapy
What this trial is about
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.
Who can take part
Age range
7 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Baylor College of Medicine - Houston, Texas, United States