Recruiting

Combined Medication

Sponsor:

Joseph Blader

Code:

NCT00794625

Conditions

Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

Valproate

Risperidone

Placebo

Stimulant medication

Behavioral family counseling

Study Details

Brief 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

Study ID

NCT00794625

Start date

Nov, 2008

Status verified date

Jul, 2012

Completion date

Apr, 2013

Anticipated

Primary completion date

Nov, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Presence of ADHD
  • Presence of persistent, clinically significant aggression
  • Presence of ODD or CD

Exclusion Criteria:

  • Presence of psychosis
  • Presence of a major developmental disability
  • Presence of a major mood disorder
  • Contraindications to stimulant, valproate, or risperidone treatment

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add valproate and behavioral family counseling to their treatment during Phase 2. If they do not respond to valproate, they will be switched to risperidone.

experimental: 2

During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add risperidone and behavioral family counseling to their treatment during Phase 2. If they do not respond to risperidone, they will switch to valproate.

placebo comparator: 3

During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add placebo and behavioral family counseling to their treatment during Phase 2.

Interventions

Valproate

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

Risperidone

Standard therapeutic doses of risperidone for 8 weeks

Placebo

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

Stimulant medication

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

Behavioral family counseling

Weekly behavioral counseling with a therapist

Primary outcome measure

  • Aggressive behavior [ Time Frame: Measured weekly for 11 to 16 weeks ]

Central Contacts and Locations

Central contacts

Joseph C. Blader, PhD, MSc

631-632-8317joseph.blader@stonybrook.edu

Lauren M. Chorney, PhD

631-632-8317lauren.chorney@stonybrook.edu

Locations

North Shore - LIJ Health System, Zucker Hillside Hospital

Recruiting

Glen Oaks, New York, United States, 11040

Contacts

Ingrid S Fuentes, BA

718-470-8487isfuentes@nshs.edu

Allison Berest, BA

718-470-8868nkatsiot@nshs.edu

Principal Investigator:

Vivian Kafantaris, MD

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794-8790

Contacts

Lauren M Chorney, PhD

631-632-8317lauren.chorney@stonybrook.edu

Gabrielle A Carlson, MD

(631) 632-8842gabrielle.carlson@stonybrook.edu

Principal Investigator:

Joseph C. Blader, PhD, MSc

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Candy Rhine

210-614-7070rhine@uthscsa.edu

Maria Silva

(210) 614-7070maria@cgcsanantonio.org

Principal Investigator:

Steven Pliszka, MD

More Information

Sponsor

Joseph Blader

Last update posted

Jul 16, 2012

Last verified

Jul, 2012

Keywords

  • Attention-Deficit/Hyperactivity Disorder
  • Aggressive Behavior
  • Oppositional Defiant Disorder
  • Conduct Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joseph Blader on 2012-07-16.