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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of South Florida
• Collaborator: Massachusetts General Hospital
• Treatments: Cycloserine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.