Atomoxetine, Placebo and Parent Management Training in Autism (Strattera)

University of Rochester

Status and phase: Completed; Phase 4

Conditions: Pervasive Development Disorder; Asperger's Disorder; Attention Deficit Hyperactivity Disorder; Autism

Treatments: Behavioral: Parent Management Training; Drug: Placebo; Drug: atomoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00844753

1R01MH079082-01A2

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

128 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Atomoxetine + Parent Management Training

Treatment:

Behavioral: Parent Management Training

Drug: atomoxetine

2

Active Comparator group

Description:

Atomoxetine without Parent Management Training

Treatment:

Drug: atomoxetine

3

Placebo Comparator group

Description:

Placebo + Parent Management Training

Treatment:

Behavioral: Parent Management Training

Drug: Placebo

4

Placebo Comparator group

Description:

Placebo without Parent Management Training

Treatment:

Drug: Placebo