NCT00198107 - Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions

Autistic Disorder

Interventions

DRUG

Aripiprazole

Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 kg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.

DRUG

Placebo

Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.

DRUG

D-cycloserine

D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.

Trial Locations (1)

46202

Riley Hospital for Children, Christian Sarkine Autism Treatment Center, Indianapolis

All Listed Sponsors

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Indiana University

OTHER