NCT00794625 - Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study) | Biotech Hunter

Enrollment

270

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

November 30, 2012

Study Completion Date

April 30, 2013

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Valproate

Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks

DRUG

Risperidone

Standard therapeutic doses of risperidone for 8 weeks

DRUG

Placebo

An inactive substance at identical dosing to active treatments for 8 weeks

DRUG

Stimulant medication

Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine

BEHAVIORAL

Behavioral family counseling

Weekly behavioral counseling with a therapist

Trial Locations (3)

RECRUITING

North Shore - LIJ Health System, Zucker Hillside Hospital, Glen Oaks

RECRUITING

University of Texas Health Science Center at San Antonio, San Antonio

RECRUITING

Stony Brook University Medical Center, Stony Brook