Clinical trial NCT05609916: CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Official title: CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Behavioral Therapy
Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children
Obsessive-Compulsive Disorder in Adolescence
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: 7 days
Secondary outcomes:
measure: Clinical Global Impression-Improvement
timeFrame: 7 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: