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Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)

NCT00794625 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2012-07-16

No results posted yet for this study

Summary

This study will determine the advantages and disadvantages of adding one of two different types of drugs to stimulant treatment for reducing aggressive behavior in children with attention deficit with hyperactivity disorder (ADHD).

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

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Northwell Health

    collaborator OTHER

  • Joseph Blader

    lead NIH

Principal Investigators

  • Joseph C. Blader, PhD, MSc · Stony Brook University School of Medicine, State University of New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-11-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00794625 on ClinicalTrials.gov