Using CBT to help kids with OCD stop medication safely
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
This study is testing if kids and teens with OCD can safely stop their medication after getting extra help from online therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05609916 on ClinicalTrials.gov |
What this trial studies
This study investigates whether children and adolescents with obsessive-compulsive disorder (OCD) can safely discontinue their medication after receiving cognitive-behavioral therapy (CBT) augmentation. Participants aged 7 to 17 who have been on stable serotonin reuptake inhibitors (SRI) for at least 12 weeks will first undergo a web-based CBT program for 12 to 18 weeks. Those who show significant improvement will then be randomized to either continue their medication or gradually switch to a placebo while receiving ongoing CBT support for 24 weeks. The study also includes genomic sample banking for future research on OCD.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 7 to 17 with a primary diagnosis of OCD who have been on stable SRI medication for at least 12 weeks.
Not a fit: Patients with severe psychiatric conditions or those currently receiving other forms of psychotherapy for OCD may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow pediatric patients with OCD to discontinue medication without experiencing a relapse.
How similar studies have performed: While the combination of CBT and medication has shown effectiveness in treating OCD, this specific approach to medication discontinuation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Eric A Storch, Ph.D.
- Email: eric.storch@bcm.edu
- Phone: 713-798-3080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.