Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder

Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).

Study Start Date

January, 01 2018

Estimated Completion Date

September 2020

Interventions

  • Drug: AVP-786
  • Drug: Placebo

Study ID

Avanir Pharmaceuticals -- 17-AVP-786-206

Status

Recruiting

Trial ID

NCT03420222

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

150

Sponsor

Avanir Pharmaceuticals

Inclusion Criteria

  • Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)
  • At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
  • Score ? 12 on the Life History of Aggression scale at screening
  • Score ? 6 on the Overt Aggression Scale
  • Modified (OAS-M) Total Irritability at screening and baseline
  • Score ? 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline

Exclusion Criteria

  • Diagnosis of major depressive disorder within 6 months of screening
  • Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score ? 10 at screening
  • Met only the DSM-5 A2 criterion for IED
  • Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
  • Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)

Gender

All

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
Montefiore Medical Center - Bronx, New York 40.3 miles None None None
Manhattan Behavioral Medicine - New York, New York 50.1 miles None None None
BTC of New Bedford - New Bedford, Massachusetts 119.7 miles None None None
Research Institute Lindner Center of HopeUniversity of Cincinnati - Mason, Ohio 598.4 miles None None None
University of Chicago Medical Center Clinical Trial Site 2 - Chicago, Illinois 744.7 miles None None None
University of Chicago Medical Center Clinical Trial Site 1 - Chicago, Illinois 744.7 miles None None None
Atlanta Center for Medical Research - Atlanta, Georgia 808.0 miles None None None
Psychiatric Care and Research Center - O'Fallon, Missouri 926.7 miles None None None
Sarkis Clinical Trials - Gainesville, Florida 952.8 miles None None None
Atlea Research Institute - Las Vegas, Nevada 2,272.6 miles None None None

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