Clinical Trial Details

Overview

Research Study Summary

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 Conjunction with Standard ADHD Treatment

Purpose

To assess the efficacy and safety of SPN-810 in reducing the frequency of impulsive aggression (IA) behaviors in pediatric patients with ADHD when taken in conjunction with standard ADHD treatment.

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CW ID: 213637
Date Last Changed: March 9, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
6 to 12 Years
Overall Status
Recruiting
Lead Sponsor
Supernus Pharmaceuticals, Inc.
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication
  • IA will be confirmed at screening using R-MOAS and Vitiello Aggression Scale

Exclusion Criteria:

  • Current or lifetime diagnosis of epilepsy, major depressive disorder, 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 as primary diagnosis

Contact

Colleen Figueroa
University of South Florida - USF Health Psychiatry Center
3515 E Fletcher Ave
Tampa, FL 33613
Phone: (813) 974-9104

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