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

Purpose

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

Condition

  • Intermittent Explosive Disorder

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - 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

Exclusion Criteria

  • 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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AVP-786 		Participants were to receive AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants were to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
  • Drug: AVP-786
    oral capsules
Placebo Comparator
Placebo 		Participants were to receive placebo BID for 12 weeks.
  • Drug: Placebo
    oral capsules

More Details

Status
Terminated
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact

Detailed Description

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.