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

• Status: Terminated
• Trial end date: 2018-12-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avanir Pharmaceuticals

Criteria

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)