D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Obsessive-compulsive Disorder

In brief

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.

Key facts

Study ID

NCT01411774

Run by

University of South Florida

People needed

142

Starts

2011-06-01

Expected to finish

2017-06-01

Last updated by the study team

2018-01-23

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• University of South Florida — St. Petersburg, Florida, United States
• Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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