Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
AutismAttention Deficit Disorder With Hyperactivity
Interventions
DRUG

Methylphenidate-extended release

Methylphenidate-extended release was taken in the morning of the MPH treatment trial. Each participant underwent 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 10 mg Ritalin LA to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took from 10 mg Ritalin LA to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 20 mg Ritalin LA to 40 mg.

DRUG

Methylphenidate-immediate release

Methylphenidate-immediate release was taken in the late afternoon. Each participant underwent 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 2.5 mg IR-MPH and 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took 2 weeks of 5 mg IR-MPH and 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 1 week of 5 mg IR-MPH and 2 weeks of 10 mg.

OTHER

Placebo

Participants will take a placebo for 1 full week of the randomized drug trial. They will take one capsule in the morning and one capsule in the afternoon.

Trial Locations (1)

77054

University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

The University of Texas Health Science Center, Houston

OTHER

NCT00178503 - Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children | Biotech Hunter | Biotech Hunter