This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by R. Lindsey Bergman, University of California, Los Angeles.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
R. Lindsey Bergman, University of California, Los Angeles Identifier:
First received: September 13, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted

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: Quadruple (Participant, Care Provider, 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 R. Lindsey Bergman, 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) ]
    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


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01687140

United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Lindsey Bergman, PhD    310-825-2373   
Contact: Allison Vreeland, BA    310-206-1350   
Principal Investigator: Lindsey Bergman, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Principal Investigator: Lindsey Bergman University of California, Los Angeles
  More Information

Responsible Party: R. Lindsey Bergman, Principle Investigator, University of California, Los Angeles Identifier: NCT01687140     History of Changes
Other Study ID Numbers: NCT003135
Study First Received: September 13, 2012
Last Updated: September 13, 2012

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 23, 2017