The Use of D-Cycloserine to Augment CBT for Pediatric OCD (DCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
R. Lindsey Bergman, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01687140
First received: September 13, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

Pediatric obsessive compulsive disorder (OCD) is a relatively common and often severe condition that can become chronic if untreated. One of the most effective treatments for OCD is a type of cognitive behavioral therapy called exposure and response prevention (ERP). ERP involves presenting a patient with feared objects or situations (the content of their obsessional fears) in a gradual manner while helping them use coping techniques to refrain from engaging in rituals (compulsions). Despite several studies suggesting that ERP is an effective treatment for pediatric OCD, many youngsters fail to respond to this treatment, or respond only partially.

An exciting recent finding from animal research is the ability of an established antibiotic (traditionally used to treat Tuberculosis), D-cycloserine (trade name: Seromycin) to enhance certain types of learning among rats. The type of learning that is enhanced is called extinction learning and many researchers believe that extinction learning is the equivalent process to what occurs during ERP; it is the process whereby repeated exposure to the object of fear without any bad outcome causes the object to cease being associated with danger. Several clinical trials using ERP and other forms of exposure treatment for adults with anxiety disorders reproduced this finding from the animal literature; pairing DCS with exposure treatment (comparable to extinction learning) resulted in greater fear reduction than when no DCS was administered. The effects of DCS on exposure treatment for anxiety disorders among children has been tested only preliminarily in one study of children with OCD and results were unclear with children who received DCS augmentation showing non-significant but increased levels of improvement as compared with children who did not receive DCS augmentation.

In this study, 26 youngsters ages 7-17 with a primary diagnosis of OCD will be recruited and assigned at random to one of the two treatment conditions. Youth in the DCS condition of the study will receive 50 mg DCS 1 hr prior to each treatment session, while youth in the placebo condition receive an identical placebo capsule 1 hr prior to each treatment augmentation session. All participants will receive 180 minutes of CBT for OCD 4 days per week for 2 weeks during their study participation (as included in IOP already). All families complete a thorough evaluation no more than 5 days prior to receiving DCS on their 9th treatment visit in IOP (third week), and at mid-treatment augmentation (after the 12th IOP treatment session), post-treatment augmentation (after the 16th IOP treatment session), and 3-month follow-up (12 weeks after the 16th IOP treatment session). The primary aim of this study is to obtain preliminary data comparing the effects of the acute administration of DCS versus placebo on symptom response to exposure treatment for pediatric OCD. Results from this study will help to inform and refine future studies, and eventually, impact treatments for pediatric OCD.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: D-Cycloserine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of D-Cycloserine to Augment Intensive Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • OCD symptom severity on the Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) [ Time Frame: Post-treatment (Study day 9) ] [ Designated as safety issue: No ]
    Treatment outcome will be evaluated based on decreases in total OCD symptom severity as measured by the CYBOCS.


Estimated Enrollment: 26
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participant takes one pill of placebo a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).
Drug: Placebo
Take one pill a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).
Active Comparator: DCS
Participant takes one pill of D-Cycloserine a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).
Drug: D-Cycloserine
Take one pill a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 7 through 17 inclusive at the time of initial evaluation.
  • Meets DSM-IV diagnostic criteria for OCD.
  • Child is fluent English speaker.
  • Parent Informed Consent and Child Informed Assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.

Exclusion Criteria:

  • IQ < 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
  • Excessive or Problematic Substance Use or DSM-IV Conduct Disorder within the past 3 months.
  • Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder.
  • Any serious psychiatric, pscyhosocial, or neurological condition (i.e., ADHD, MDD, anxiety, severe aggression, family discord) requiring immediate treatment).
  • Presence of primary hoarding symptoms or mental rituals.
  • Having epilepsy, renal insufficiency, or generally poor physical health.
  • Pregnancy or having unprotected sex (in females).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687140

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Lindsey Bergman, PhD    310-825-2373    lbergman@mednet.ucla.edu   
Contact: Allison Vreeland, BA    310-206-1350    avreeland@mednet.ucla.edu   
Principal Investigator: Lindsey Bergman, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Lindsey Bergman University of California, Los Angeles
  More Information

No publications provided

Responsible Party: R. Lindsey Bergman, Principle Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01687140     History of Changes
Other Study ID Numbers: NCT003135
Study First Received: September 13, 2012
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014