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Stimulant

2 for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 4
Waitlist Available
Led By Joseph C. Blader, PhD, MSc
Research Sponsored by Joseph Blader
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured weekly for 11 to 16 weeks
Awards & highlights

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).

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured weekly for 11 to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured weekly for 11 to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aggressive behavior
Secondary outcome measures
ADHD symptoms

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2Experimental Treatment4 Interventions
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.
Group II: 1Experimental Treatment4 Interventions
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.
Group III: 3Placebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valproic acid
FDA approved
Risperidone
FDA approved

Find a Location

Who is running the clinical trial?

Joseph BladerLead Sponsor
University of TexasOTHER
187 Previous Clinical Trials
142,183 Total Patients Enrolled
Northwell HealthOTHER
458 Previous Clinical Trials
470,663 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
297 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
Joseph Blader 2008. "Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00794625.
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~16 spots leftby Apr 2025
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