A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

Condition(s) targeted: Autism; Attention Deficit Hyperactivity Disorder

Intervention: methylphenidate transdermal system (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Oklahoma

Official(s) and/or principal investigator(s):
Thomas M Lock, M.D., Principal Investigator, Affiliation: OU Child Study Center
Mark L Wolraich, M.D., Study Director, Affiliation: OU Child Study Center

Overall contact:
Lora Tusing, Phone: 405-271-5700, Ext: 45167, Email: lora-tusing@ouhsc.edu

This is an open-label study of the efficacy of Daytrana 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.

Official title: Phase II Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Determine if Daytrana is safe and well-tolerated by children with Autism co-morbid for ADHD

Secondary outcome:

Determine if Daytrana is safe and well tolerated by children with Autism co-morbid for ADHD

Determine if Daytrana is effective in both school and home in significantly reducing symptoms of inattention, hyperactivity and impulsivity in children with Autism co-morbid for ADHD

Determine if Daytrana improves behaviors in the mornings and evenings

Determine if parents of children with Autism co-morbid for ADHD are satisfied with the effectiveness of Daytrana

Determine if there are any differences in the adverse effects profile of children with Autism co-morbid for ADHD compared to the overall profile for Daytrana

Determine the degree of functional limitation experienced by this group of children with Autism co-morbid for ADHD and whether this impairment is decreased by treatment with Daytrana

Determine acceptability of the transdermal system to this group of patients and their caretakers

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.

Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.

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

Lora Tusing, Phone: 405-271-5700, Ext: 45167, Email: lora-tusing@ouhsc.edu

OU Child Study Center, Oklahoma City, Oklahoma 73117, United States; Recruiting

Related publications:

Abanilla PK, Hannahs GA, Wechsler R, Silva RR. The use of psychostimulants in pervasive developmental disorders. Psychiatr Q. 2005 Fall;76(3):271-81. Review.

Starting date: October 2007
Ending date: December 2008
Last updated: October 27, 2008