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A Study to Evaluate the Efficacy and Safety of Molindone Hydrochloride XR Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01364662
First received: May 25, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.


Condition Intervention Phase
Impulsive Aggression Comorbid With ADHD
 Drug: Molindone
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Reduction in aggressive behavior as assessed by R-MOAS score [ Time Frame: after approximately 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: after approximately 6 weeks ] [ Designated as safety issue: Yes ]
    Safety as assessed by safety scales, AEs, clinical labs, vitals, PEs, ECGs, etc


Estimated Enrollment: 120
Study Start Date: June 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Placebo
administered orally twice daily
Experimental: 2 Drug: Molindone
administered orally twice daily
Experimental: 3 Drug: Molindone
administered orally twice daily
Experimental: 4 Drug: Molindone
administered orally twice daily

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy pediatric male or female subjects, age 6 to 12 years.
  2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
  3. R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
  4. IQ greater than 71.
  5. Weight of >=20kg
  6. current treatment with psychostimulant (1 month prior to screening)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364662

  Show 28 Study Locations
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01364662     History of Changes
Other Study ID Numbers: 810P202
Study First Received: May 25, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Supernus Pharmaceuticals, Inc.:
Impulsive Aggression
Attention Deficit Hyperactivity Disorder
ADHD

Additional relevant MeSH terms:
Aggression
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Molindone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013