Clinical Trial Details

Overview

Research Study Summary

Study Seeking Patients with ADHD with Aggression

Purpose
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MOLINDONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS FOR THE TREATMENT OF IMPULSIVE AGGRESSION IN PEDIATRIC PATIENTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CONJUECTION WITH STANDARD ADHD TREATMENT
To Learn more

CW ID: 223952
Date Last Changed: March 30, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
6 to 12 Years
Overall Status
Recruiting
Lead Sponsor
Supernus
Duration
24 Weeks
Facility Type
Out-Patient
Compensation
Up to $525

Eligibility

Main Inclusion Criteria
  • Male or Female 6-12 years old
  • Primary diagnosis of ADHD with impulsive aggression
  • Stabilized on monotherapy treatment with an optimized FDA-approved ADHD medication for at least one month
  • Weight of at least 20kg
Main Exclusion Criteria
  • A current or lifetime diagnosis of epilepsy, MDD, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette’s disorder, or psychosis not otherwise specified
  • Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder
  • Use of anticonvulsants, antidepressants, mood stabilizers, benzodiazepines, cholinesterase inhibitors within 2 weeks of Visit 2

Contact

Segal Institute for Clinical Research
7481 W. Oakland Park Blvd., Suite 205
Lauderhill, FL 33319
Phone: 1-877-734-2588

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