Atomoxetine, Placebo and Parent Management Training in Autism
Condition: Autism; Pervasive Development Disorder; Asperger's Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Asperger Syndrome; Child Development Disorders, Pervasive; Autism Spectrum Disorder
Intervention: atomoxetine; Placebo; Parent Management Training
Intervention description: atomoxetine; Placebo + parent management treatment
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 128.0
Sex: All
Minimum age: 5 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: Autism; PDD NOS; Attention Deficit Hyperactivity Disorder; Parent Management Training

Summary:

      The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent
      Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive
      Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention
      Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where
      the atomoxetine will have a dose titration over a 6 week period. All children will be seen
      weekly during this titration period, with additional visits at Week 8 and Week 10. Families
      assigned to the PMT arm will have an additional weekly meeting with a clinician for a total
      of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with
      their children. Subjects who are clinical responders (ADHD Responders and Compliance
      Responders) from the 10 week study period will be followed every 4 weeks in a 24-week
      extension study. Subjects who are clinical nonresponders will continue in PMT if they
      received PMT during the double-blind phase, and they will receive an open trial of
      atomoxetine if they were on placebo during the double-blind phase. All subjects (responders
      and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for
      24 weeks after the completion of the double-blind phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 5 yrs to 14 years 11 mos with clinical diagnosis of Autism, Asperger's
             Disorder, or PDDNOS based upon the ADI-R and clinical evaluation by DSM-IV criteria,

          -  Mental age equal to or greater than 24 months,

          -  ADHD symptoms based upon the CASI and clinical confirmed diagnosis,

          -  CGIS-S rating of 4 or grater for ADHD symptoms,

          -  A mean item score of >1.5 on both the Parent and Teacher (non-parent caregiver)
             SNAP-IV 18 ADHD symptoms or the 9-symptom hyperactive-impulsive subscale (symptoms
             must be cross-situational),

          -  Reliable care provider available to bring subject to clinic visits and weekly
             sessions.

        Exclusion Criteria:

          -  DSM-IV diagnosis of schizophrenia, schizoaffective disorder psychotic disorder
             NOS,bipolar disorder, or major depression (if accompanied by a family history of
             bipolar disorder) based upon evidence of suicidality, CASI, and clinical
             interview/history,

          -  Prior failed adequate trial of atomoxetine,

          -  Use of other psychotropic medications that produce CNS effects,

          -  Diagnosis of bipolar disorder, major depression, hypertension, cardiovascular disease,
             narrow angle glaucoma, other significant physical illness,

          -  Pregnancy or sexually active females (intercourse in the past 6 months, reported by
             either the subject or caregiver),

          -  Currently on effective medication treatment for ADHD,

          -  Prior involvement in Parent Management Training or other similar program,

          -  Currently on albuterol or taking beta blockers,

          -  Taking supplements or other complementary medical treatments where dose cannot be held
             at current level for duration of study