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
| Arm | Description | Assigned 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. |
|
|
Placebo Comparator Placebo |
Participants were to receive placebo BID for 12 weeks. |
|
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.