Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Atomoxetine, Placebo and Parent Management Training in Autism
Brief 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.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: atomoxetine, Behavioral: Parent Management Training | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: atomoxetine | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Behavioral: Parent Management Training | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: atomoxetine; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3, 4 | Intervention Type: BEHAVIORAL; Name: Parent Management Training; Assigned to Arm(s): 1, 3
B: Arm Label: Placebo for AChEI and Choline; Type: PLACEBO_COMPARATOR; Interventions: Drug: Indistinguishable placebo tablets, matching both donepezil and choline | Arm Label: AChEI and Choline; Type: EXPERIMENTAL; Interventions: Drug: Acetyl-Choline Esterase Inhibitors and Choline supplements | Intervention Type: DRUG; Name: Acetyl-Choline Esterase Inhibitors and Choline supplements; Assigned to Arm(s): AChEI and Choline | Intervention Type: DRUG; Name: Indistinguishable placebo tablets, matching both donepezil and choline; Assigned to Arm(s): Placebo for AChEI and Choline
C: Arm Label: Lurasidone 20 mg; Type: EXPERIMENTAL; Interventions: Drug: Lurasidone 20 mg daily | Arm Label: Lurasidone 60 mg; Type: EXPERIMENTAL; Interventions: Drug: Lurasidone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Lurasidone 20 mg daily; Assigned to Arm(s): Lurasidone 20 mg | Intervention Type: DRUG; Name: Lurasidone; Assigned to Arm(s): Lurasidone 60 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: IGF-1; Type: EXPERIMENTAL; Interventions: Drug: IGF-1 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo/saline | Intervention Type: DRUG; Name: IGF-1; Assigned to Arm(s): IGF-1 | Intervention Type: DRUG; Name: Placebo/saline; Assigned to Arm(s): Placebo

Answer: A