CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-17
SponsorBaylor College of Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Continued SRIActive comparator 1 intervention
Group B: Discontinuation titration to placeboPlacebo comparator 1 intervention
Group C: Open label CBTOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7 days

Secondary outcomes

1

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).

Time frame
7 days

Other outcomes

Sponsors and contacts

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