Phase 3
N=142
D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)
Obsessive-compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01411774 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Children's Yale-Brown Obsessive-Compulsive Scale. — 13.53; 13.98 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cognitive-behavioral therapy (Behavioral); d-cycloserine (Drug); Pill placebo (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Yale-Brown Obsessive-Compulsive Scale. |
13.53; 13.98 | — |
| SECONDARY Clinical Global Impression-Severity |
2.23; 2.28 | .95 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01411774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.