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Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligible participants for this study must have a diagnosis of current IED.
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
