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

Otsuka

Status and phase: Terminated; Phase 2

Conditions: Intermittent Explosive Disorder

Treatments: Drug: AVP-786; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03420222

17-AVP-786-206

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

AVP-786

Experimental group

Description:

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.

Treatment:

Drug: AVP-786

Placebo

Placebo Comparator group

Description:

Participants were to receive placebo BID for 12 weeks.

Treatment:

Drug: Placebo