A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder

PHASE4CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

September 30, 2009

Study Completion Date

March 31, 2010

Conditions
Autistic DisorderAutism
Interventions
DRUG

Placebo

Oral solution qd or bid for 6 weeks

DRUG

Risperidone high dose

Risperidone oral solution 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg) qd or bid for 6 weeks

DRUG

Risperidone low dose

Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) qd or bid for 6 weeks

Trial Locations (20)

Unknown

Dothan

Phoenix

Sacramento

Santa Ana

Boca Raton

Miami

Smyrna

Hoffman Estates

Naperville

Lake Charles

Manhasset

New York

Staten Island

The Bronx

Columbus

Oklahoma City

Philadelphia

Houston

Fairfax

Portsmouth

All Listed Sponsors
lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT00576732 - A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder | Biotech Hunter | Biotech Hunter