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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Intermittent Explosive Disorder

In brief

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

Key facts

Study ID

NCT03420222

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

10

Starts

2018-01-18

Expected to finish

2018-12-28

Last updated by the study team

2022-05-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) 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 Total Irritability at screening and baseline
• Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline

You may not qualify if…

• Diagnosis of major depressive disorder within 6 months of screening
• Significant symptoms of a depressive disorder or a Patient Health Questionnaire-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)

Where it is running

• Sarkis Clinical Trials — Gainesville, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• University of Chicago Medical Center Clinical Trial Site 2 — Chicago, Illinois, United States
• BTC of New Bedford — New Bedford, Massachusetts, United States
• Psychiatric Care and Research Center — O'Fallon, Missouri, United States
• Atlea Research Institute — Las Vegas, Nevada, United States
• Manhattan Behavioral Medicine — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Research Institute Lindner Center of Hope/University of Cincinnati — Mason, Ohio, United States

Full record on ClinicalTrials.gov

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