Status:
COMPLETED
D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Obsessive-compulsive Disorder
Eligibility:
All Genders
7-17 years
Phase:
PHASE3
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 ...
Detailed Description
Obsessive-compulsive disorder (OCD) affects 1-2% of children, runs a chronic course without treatment, and is associated with considerable functional impairment and poor quality of life. Although most...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01411774
Start Date
June 1 2011
End Date
June 1 2017
Last Update
January 23 2018
Active Locations (2)
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1
University of South Florida
St. Petersburg, Florida, United States, 33701
2
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138