Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Atomoxetine, Placebo and Parent Management Training in Autism
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06129396 -
Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT04779333 -
Lifestyle Enhancement for ADHD Program 2
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
Completed |
NCT04832737 -
Strength-based Treatment Approach for Adults With ADHD
|
N/A | |
Recruiting |
NCT04631042 -
Developing Brain, Impulsivity and Compulsivity
|
||
Recruiting |
NCT05048043 -
Development of a Game-supported Intervention
|
N/A | |
Completed |
NCT03337646 -
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
|
Phase 4 | |
Not yet recruiting |
NCT06406309 -
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
|
N/A | |
Not yet recruiting |
NCT06454604 -
Virtual Reality Treatment for Emerging Adults With ADHD
|
Phase 2 | |
Not yet recruiting |
NCT06080373 -
Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT02477280 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance
|
Phase 4 | |
Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
Completed |
NCT02555150 -
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
|
Phase 3 | |
Completed |
NCT02780102 -
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
|
N/A | |
Completed |
NCT02390791 -
New Technologies to Help Manage ADHD
|
N/A | |
Completed |
NCT02473185 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest
|
Phase 4 | |
Recruiting |
NCT04175028 -
Neuromodulation of Executive Function in the ADHD Brain
|
N/A | |
Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A |