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D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)

NCT01411774 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-01-23

Study results available
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Summary

The investigators are conducting a randomized double-blind placebo-controlled study to assess the efficacy of d-cycloserine augmentation of cognitive-behavioral therapy for the treatment of pediatric obsessive compulsive disorder. This study represents an innovative approach in translating bench research findings into clinical research and testing a new approach for optimizing an effective psychotherapy with a safe non-psychotropic medication.

Conditions

  • Obsessive-compulsive Disorder

Interventions

BEHAVIORAL

Cognitive-behavioral therapy

All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.

DRUG

d-cycloserine

D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg). Accordingly, doses for this study will be about 0.7mg/kg. Two dosing levels will be used based upon weight ranges to ensure comparable mg/kg levels: children weighing 25-45kg will be given a dosage of 25mg (\~0.56-1.0 mg/kg/day), and children ≥46kg will be given 50mg provided in two 25mg capsules (\~0.50-1.08mg/kg/day). Doses will be given 1 hour before therapy sessions 4-10.

DRUG

Pill placebo

The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • University of South Florida

    lead OTHER

Principal Investigators

  • Eric Storch, Ph.D. · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01411774 on ClinicalTrials.gov