CBT Augmentation for Pediatric OCD Medication Discontinuation

This study is for children and adolescents aged 7 to 17 who have Obsessive-Compulsive Disorder (OCD) and are currently taking stable antidepressant medication (SRI). The study wants to see if adding Cognitive Behavioral Therapy (CBT) can help young people with OCD successfully stop taking their medication without their symptoms returning. All participants will first receive 12 to 18 weeks of web-based CBT. If their OCD symptoms improve enough, they will then be randomly assigned to either continue their SRI medication or gradually stop it, while still receiving ongoing CBT maintenance sessions. The main goal is to see if participants can discontinue their medication without relapse over 24 weeks. This study is currently unclear about its recruitment status.

Study design
This interventional study plans to enroll 200 participants. It involves two phases: an initial open-label CBT phase, followed by a randomized, placebo-controlled phase.
What's involved
You would receive 12 to 18 weeks of web-based CBT, followed by CBT maintenance sessions every two to four weeks for 24 weeks, along with medication visits.
Compensation
Not stated in the trial record.
Follow-up
All participants will complete a follow-up assessment 12 months after the end of Phase II.

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NCT05609916

CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Recruiting
NAAges 7–17InterventionalTreatment
Baylor College of Medicine
~200 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Measured over 7 days
Cognitive Behavioral Therapy
Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children
Obsessive-Compulsive Disorder in Adolescence
1 sites across 1 states
Texas1

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Eligibility criteria

Inclusion

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

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.
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)7 days

    Clinician-rated child OCD symptoms and severity throughout the past week. The scale has a checklist of obsessions and compulsions, followed by severity items each scored on a 0 to 4 scale.