NCT05609916 · Baylor College of Medicine
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: 7 days
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Exclusion criteria
- ary 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
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations