Clinical trial NCT00541346: A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Official title: Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism
Attention Deficit Hyperactivity Disorder
Keywords: Autism
Autism Spectrum Disorders
ADHD
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Mark L. Wolraich, M.D.
First posted: 2007-10-10
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed.

The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.

Detailed description: The design will be an open-label trial of eight weeks duration with 20 children with Autism co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. After each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.

Eligibility criteria: Inclusion Criteria:

* Between 6 and 11 years
* Autism Spectrum Disorder
* Attention Deficit Hyperactivity Disorder
* Stimulant medication-free at study entry
* No clinically significant abnormalities that preclude safe participation
* Sufficient developmental level (\~3 yrs)
* Able to keep appointments
* Able to communicate effectively
* Teacher cooperation

Exclusion Criteria:

* Received an investigational medication in the previous 30 days
* Current medication treatment is effective and well-tolerated
* Medical conditions that affect patient safety
* MAOIs within one month
* Hypertension
* Bipolar disorder or psychosis
* Anticonvulsants
* Psychotropic medication or health food supplement
* Tourette Disorder
* Seizure disorder
* Neurological condition
* Structural heart disease

Primary outcomes:
measure: Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
measure: Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Child Study Center
state: Oklahoma
Study officials:
affiliation: OU Child Study Center
name: Thomas M Lock, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: OU Child Study Center
name: Mark L Wolraich, M.D.
role: STUDY_DIRECTOR
References:
citation: Abanilla PK, Hannahs GA, Wechsler R, Silva RR. The use of psychostimulants in pervasive developmental disorders. Psychiatr Q. 2005 Fall;76(3):271-81. doi: 10.1007/s11126-005-2980-7.