NCT05609916 CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
| NCT ID | NCT05609916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Cognitive Behavioral Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-11-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-11-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05609916 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Cognitive Behavioral Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05609916 currently recruiting?
Yes, NCT05609916 is actively recruiting participants. Contact the research team at eric.storch@bcm.edu for enrollment information.
Where is the NCT05609916 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05609916 clinical trial?
NCT05609916 is sponsored by Baylor College of Medicine. The trial plans to enroll 200 participants.