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

NCT01687140 | Unknown Phase 2 DMC

• 1 other identifier: NCT003135
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• OCD symptom severity on the Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)

  Treatment outcome will be evaluated based on decreases in total OCD symptom severity as measured by the CYBOCS.

  Post-treatment (Study day 9)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

DCS

ACTIVE COMPARATOR

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

Interventions

D-Cycloserine DRUG

Take one pill a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).

DCS

Placebo DRUG

Take one pill a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).

Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Lindsey Bergman

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

US (1)