CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609916
• Other study ID #: H-52089
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: Eric A Storch, Ph.D.
• Phone: 713-798-3080
• Email: eric.storch[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pediatric obsessive-compulsive disorder (OCD) is a common, chronic, and severe psychiatric disorder. Currently, many youth with OCD are treated with medication, such as a serotonin reuptake inhibitor (SRI); however, only a subset of them responds to SRI. Data show that the addition of cognitive-behavioral therapy (CBT) to SRI partial responders is effective although extended SRI use with CBT can attenuate combined treatment outcomes. This placebo-controlled study will enroll pediatric OCD patients to examine if those who benefit from CBT augmentation can discontinue their SRI successfully without relapse over 24-weeks. This study will also bank genomic samples for future analysis when polygenic risk scores for OCD may become available. This study will be conducted in two phases. In Phase I, all participants will receive a web-based CBT for 12 to 18 weeks. At the end of Phase I, those who achieve wellness indicated by CY-BOCS ≤ 12 and ≥ 50% reduction since baseline for 3 consecutive weeks, will go on to the next phase. In Phase II, participants will be randomized into two groups: 1) Continued SRI and 2) Discontinuation titration to placebo. In this phase, all participants will receive web-based CBT maintenance sessions and attend medication visits for 24 weeks. At 12 months after the end of Phase II, all participants will complete a follow-up assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive Behavioral Therapy
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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	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.	7 days
Secondary	Clinical Global Impression-Improvement	Clinician-rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved).	7 days