D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)
Condition: Obsessive-compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Cognitive-behavioral therapy; d-cycloserine; Pill placebo
Intervention description: 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.).
Intervention MeSH terms: Cycloserine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obsessive-compulsive disorder; OCD

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.