D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder
Condition: Obsessive-compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Cognitive-behavioral therapy; D-cycloserine; Placebo pill
Intervention description: All patients will receive 10 sessions of therapy over 8 weeks that is based on the protocol used in POTS (2004). Sessions 1-4 will be held twice weekly; thereafter sessions will be held on a weekly basis. This evidence-based E/RP intervention (POTS, 2004) includes psychoeducation, cognitive training, and exposure and response prevention. By design, this manual provides sufficient flexibility to accommodate the child's developmental needs and address maladaptive parent-child interactions (e.g., accommodation).; D-cycloserine (Seromycin, 250 mg; Eli Lilly and Co, Indianapolis, Indiana) will be capsulated into 25mg with identical placebo capsules. Children weighing between 25-45kg will be given a dosage of 25mg (approximately 0.56-1.0 mg/kg/day). Children weighing between 46-80kg will be given a dosage of 50mg (approximately 0.63-1.08mg/kg/day). DCS or placebo will be given by parents 1 hour prior to psychotherapy sessions (before sessions 4-10 only) based on past success in patients with acrophobia (Ressler et al., 2004) and DCS absorption rates.; This intervention involves taking a placebo pill(s) that matches the d-cycloserine capsules in size, shape, weight, and taste. Placebo contains an no active medication.
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obsessive-compulsive disorder

Summary:

      Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric
      obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who
      benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults
      with other anxiety disorders (acrophobia and social phobia) provided support for using a
      medication called D-Cycloserine (DCS) to enahnce the outcome of exposure-based psychotherapy.
      Given this, DCS may augment CBT in youth with OCD, an anxiety disorder that is conceptually
      similar to acrophobia. With this in mind, the investigators are conducting a randomized,
      double-blind placebo controlled pilot study of DCS to determine whether it had any short-term
      clinical benefits on CBT in youth with OCD. Forty children and adolescents (ages 8-17) with a
      primary diagnosis of OCD will be screened and, should they meet relevant criteria, randomly
      assigned to one of two treatment conditions: (1) CBT plus DCS, or (2) CBT plus placebo. All
      patients will receive 10 sessions of CBT A rater will assess participants at 3 separate time
      points.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The child must receive a principal diagnosis of OCD at Baseline, based on DSM-IV
             criteria. This diagnosis will be derived from the Anxiety Disorder Interview Schedule
             for DSM-IV-Child Interview Schedule - Parent version (ADIS-IV-P), and must reflect a
             clinical severity rating of 4 or above

          -  CY-BOCS Total Score ≥ 16

          -  Be between the ages of 8 and 17 years

          -  Score ≥ 80 on the Peabody Picture Vocabulary Test-3rd Edition (Dunn & Dunn, 1997)

          -  At least one parent available to accompany the child to all sessions;

          -  English speaking.

        Exclusion Criteria:

          -  Psychosis, pervasive developmental disorder, bipolar disorder, or current suicidal
             intent measured by the ADIS-IV-P and all available clinical information

          -  Principal diagnosis other than OCD

          -  Youth with mental rituals, incompleteness, or hoarding symptoms as E/RP exercises
             would be more difficult to conduct/monitor than those with overt rituals

          -  Unavailability of at least one caregiver to participate in the treatment

          -  Refusal of parent to accept random assignment to treatment condition

          -  A positive diagnosis in the caregiver of mental retardation, psychosis, clinically
             significant tics, or other psychiatric disorders or conditions that would limit their
             ability to understand E/RP (based on clinical interview)

          -  Weight less than 25.0 kg or greater than 80.0kg

          -  Epilepsy, renal insufficiency, and current or past history of alcohol abuse (DCS is
             contraindicated for such conditions)

          -  Pregnant or having unprotected sex [in females] as the effects of DCS on pregnant
             youth are unknown

          -  General poor physical health as determined by medical physical and laboratory tests.