CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05609916
Status
Recruiting
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Conditions

  • Cognitive Behavioral Therapy
  • Obsessive-Compulsive Disorder
  • Obsessive-Compulsive Disorder in Adolescence
  • Obsessive-Compulsive Disorder in Children

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy — BEHAVIORAL
    During Phase I, participants will receive open label (no blinding) CBT during their study participation for 12 to 18 weeks. During Phase II, participants will continue receiving CBT maintenance sessions every two weeks for the first 4 weeks, followed by sessions every four weeks. They will also meet with the study physician every 2 weeks via telepsychiatry appointments for clinical and scalar assessment.

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Jul 2025
Primary completion
Dec 30, 2026
Completion
Aug 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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participants, the placebo substitution in an increasing proportion of capsules will be implemented until all drug is withdrawn.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.

Primary Outcome Measure

Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Alyssa Hertz
[email protected]

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