CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Eric A Storch, Ph.D.
eric.storch@bcm.edu
713-798-3080
Time Frame
Start Date: 2022-11-30
Estimated Completion Date: 2027-08-30
Participants
Target number of participants: 200
Treatments
Active_comparator: Continued SRI
After post-phase I assessment, participants who are eligible will be randomized to 1) Continued SRI. For these participants, the medication (SRI) will be provided at a consistent dosage.
Placebo_comparator: Discontinuation titration to placebo
After post-phase I assessment, participants who are eligible will be randomized to 2) Discontinuation titration to placebo. For these participants, the placebo substitution in an increasing proportion of capsules will be implemented until all drug is withdrawn.
Other: Open label CBT
During Phase I, all participants will receive open label cognitive-behavioral therapy. Only those who achieve significant benefit will be able to most on to the post-phase I assessment, and then to the random assignment to Continued SRI or Discontinuation titration to placebo arms.
Related Therapeutic Areas
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov