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


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


  • Drug: AVP-786
  • Drug: Placebo

Study ID

Avanir Pharmaceuticals -- 17-AVP-786-206



Trial ID


Study Type


Trial Phase

Phase 2

Enrollment Quota



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)




18 Years to 65 Years

Accepts Healthy Volunteers


Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
BTC of New Bedford - New Bedford, Massachusetts 26.3 miles None None None
Montefiore Medical Center - Bronx, New York 176.6 miles None None None
Manhattan Behavioral Medicine - New York, New York 186.5 miles None None None
Research Institute Lindner Center of HopeUniversity of Cincinnati - Mason, Ohio 722.2 miles None None None
University of Chicago Medical Center Clinical Trial Site 2 - Chicago, Illinois 848.0 miles None None None
University of Chicago Medical Center Clinical Trial Site 1 - Chicago, Illinois 848.0 miles None None None
Atlanta Center for Medical Research - Atlanta, Georgia 944.5 miles None None None
Psychiatric Care and Research Center - O'Fallon, Missouri 1,045.1 miles None None None
Sarkis Clinical Trials - Gainesville, Florida 1,083.3 miles None None None
Atlea Research Institute - Las Vegas, Nevada 2,376.4 miles None None None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.