D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)
1/2 D-cycloserine Augmentation of CBT for Pediatric OCD
1 other identifier
interventional
142
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2011
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
January 23, 2018
CompletedJanuary 23, 2018
October 1, 2017
5 years
June 10, 2011
November 30, 2017
December 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Children's Yale-Brown Obsessive-Compulsive Scale.
The Children's Yale-Brown Obsessive-Compulsive Scale measures the severity of OCD symptoms. There are 10 questions that are summed to arrive at a total score, with higher scores representing more severe OCD symptoms (scores range from 0-40).
10 weeks
Secondary Outcomes (1)
Clinical Global Impression-Severity
10 weeks
Study Arms (2)
Cognitive-behavioral therapy plus pill placebo
ACTIVE COMPARATORThis study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.
Cognitive-behavioral Therapy plus d-cycloserine
EXPERIMENTALThis study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.
Interventions
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.
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.
The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).
Eligibility Criteria
You may qualify if:
- Outpatient youth with obsessive-compulsive disorder between the ages 7-17 years.
- A Children's Yale-Brown Obsessive-Compulsive Scale score ≥ 16
- Child has a Full Scale IQ≥85 as assessed on the WASI (within 90% CI).
- English speaking
You may not qualify if:
- Receiving concurrent psychotherapy or a past adequate trial of CBT for OCD. Families will have the option of discontinuing such services to enroll in the study.
- New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
- Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxioloytics, stimulant, alpha agonist) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications must be stable for 6 weeks prior to baseline.
- Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded.
- DSM-IV conduct disorder, autism, bipolar, schizophrenia or schizoaffective disorders; or substance abuse in past 6 months using all available information.
- Youth with hoarding symptoms that are their primary form of OCD.
- Weight less than 25.0 kg.
- Epilepsy, renal insufficiency, and current/past history of alcohol abuse.
- Pregnant or having unprotected sex \[in females\] as the effects of d-cycloserine on pregnancy are unknown.
- Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.
- Known d-cycloserine allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- Massachusetts General Hospitalcollaborator
Study Sites (2)
University of South Florida
St. Petersburg, Florida, 33701, United States
Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
Related Publications (1)
Storch EA, Murphy TK, Goodman WK, Geffken GR, Lewin AB, Henin A, Micco JA, Sprich S, Wilhelm S, Bengtson M, Geller DA. A preliminary study of D-cycloserine augmentation of cognitive-behavioral therapy in pediatric obsessive-compulsive disorder. Biol Psychiatry. 2010 Dec 1;68(11):1073-6. doi: 10.1016/j.biopsych.2010.07.015.
PMID: 20817153BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We did not measure distress ratings within each exposure session, which prohibits examining whether D-cycloserine enhances outcomes when within-session distress reduction is achieved. The sample was primarily of white race/ethnicity.
Results Point of Contact
- Title
- Dr. Eric Storch
- Organization
- Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Storch, Ph.D.
University of South Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2011
First Posted
August 8, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2016
Study Completion
June 1, 2017
Last Updated
January 23, 2018
Results First Posted
January 23, 2018
Record last verified: 2017-10