D-Cycloserine and Social Skills Training in Autism Spectrum Disorders
Condition: Autistic Disorder; Asperger's Disorder; Pervasive Developmental Disorder NOS
MeSH terms: Autism Spectrum Disorder; Autistic Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Intervention: D-cycloserine; Placebo
Intervention description: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions; Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions
Intervention MeSH terms: Cycloserine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Autism Spectrum Disorder; D-cycloserine; Social Skills Training

Summary:

      The purpose of this study is to determine the effectiveness of D-cycloserine for improving
      social impairment in child with pervasive developmental disorders (PDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV-TR diagnosis of autism, Asperger's disorder, or PDD not otherwise specified
             (NOS) base on a semi-structured review of DSM-IV-R criteria and mental status
             examination as wll as a complete parental history obtained from the Autism Diagnostic
             Interview-Revised (ADI-R) and a complete systematic patient interview utilizing the
             Autism Diagnostic Observation Schedule (ADOS).

          -  Males and females ages 5-11 years.

          -  Significant social impairment as evidenced by a parent-rated Social Responsiveness
             Scale (SRS) T-score of 60 or greater.

          -  TSSA score of 70% or less on both parent questionnaire and child assessment. Children
             not showing significant impairment in the four specific social skill areas
             (greetings/goodbyes, conversations, game play, and understanding emotions) targeted by
             the SST are less likely to benefit from treatment.

          -  Communication Standard Score of 70 or greater on the Vineland-II.

          -  Full Scale IQ greater than 70.

          -  Subjects must not be taking any psychotropic drugs affecting glutamate
             neurotransmission (riluzole, memantine, acamprosate, topiramate, amantadine, among
             others). Subjects may not be taking more than two psychotropic drugs. Dosing of all
             concomitant psychotropic drugs targeting core social and/or communication impairment
             must be stable for eight weeks prior to randomization. Dosing of all concomitant
             psychotropic drugs treating other features associated with pervasive developmental
             disorders (insomnia, inattention, hyperactivity, anxiety, irritability among others0
             must be stable for two weeks (with the exception of four weeks for fluoxetine) prior
             to randomization.

          -  Able to participate in group SST based on semi-structured parent and child interview.

          -  Legal guardian has provided written informed consent and the subject has provided
             written informed assent. Expectation that a majority of subjects will be able to
             assent but the potential for the younger children and/or those that are cognitively
             impaired will not be able to assent.

        Exclusion Criteria:

          -  Subjects with diagnoses of Rett's disorder or childhood integrative disorder will not
             be enrolled since these disorders have a different etiology, course, and treatment
             response. Furthermore, children with these disorders may not function at a high enough
             level in terms of cognition or language in order to benefit from the SST.

          -  Initiation of a new psychosocial intervention within 90 days prior to randomization.
             Participants who have recently had a significant change in their psychosocial
             interventions will not be eligible until this intervention has been stable for 90 days
             in order to avoid confounding results of the study. Stable interventions (e.g., speech
             and occupational therapy), with the exception of concurrent social skills training,
             will be allowed to continue during the course of the study. Minor changes in ongoing
             treatment (e.g., missed therapy sessions due to holiday/vacation; planned break in
             therapy due to school holidays) are not considered significant.

          -  Subjects exhibiting significant disruptive, aggressive, self-injurious, or sexually
             inappropriate behavior will not be eligible for enrollment.

          -  Presence of current DSM-IV-TR psychiatric disorders that require alternative
             pharmacotherapy or different treatment including psychotic disorders, or major
             affective disorders, obsessive-compulsive disorder, panic disorder, or substance
             related disorders.

          -  Presence of any medical condition that would make treatment with DCS less safe.
             Subjects with significant cardiac, hepatic, or renal disease will be excluded due to
             concerns about pharmacokinetic alterations or adverse effects. Subjects with a history
             of a seizure disorder are permitted if the subject has been seizure free for 6 months
             and is currently treated with an anticonvulsant that has been stable for 4 weeks.
             D-Cycloserine is an U.S. FDA Pregnancy Category C drug. Because of the unknown effects
             of DCS on the developing human fetus, females of childbearing potential will be given
             a urine pregnancy test and required to use a suitable form of birth control during the
             study. A positive pregnancy test result excludes the subject.

          -  Presence of any other condition that would make the participants unable to comply with
             the requirements of the study for any reason.