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

• ClinicalTrials.gov Identifier: NCT03420222
• Recruitment Status: Terminated
• First Posted: February 5, 2018
• Last Update Posted: December 24, 2019
• Sponsor: Avanir Pharmaceuticals
• Information provided by (Responsible Party): Avanir Pharmaceuticals

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Intermittent Explosive Disorder	Drug: AVP-786; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: December 28, 2018
• Actual Study Completion Date: December 28, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: AVP-786; Dose 1 capsules administered twice a day over a 12-week period	Drug: AVP-786; oral capsules
Placebo Comparator: Placebo; Placebo capsules administered twice a day over a 12-week period	Drug: Placebo; oral capsules

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score [ Time Frame: Baseline; Week 12 ]

Secondary Outcome Measures :

1. Change from Baseline to Week 12 in the OAS-M Total Irritability Score [ Time Frame: Baseline; Week 12 ]
2. Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability [ Time Frame: Baseline; Week 12 ]
3. Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days [ Time Frame: Baseline; Week 12 ]
4. Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary [ Time Frame: Baseline; Week 12 ]
5. Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes [ Time Frame: Baseline; Week 12 ]
6. Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED [ Time Frame: Baseline; Week 12 ]
7. Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED [ Time Frame: Baseline; Week 12 ]
8. Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED [ Time Frame: Baseline; Week 12 ]
9. Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED [ Time Frame: Baseline; Week 12 ]
10. Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score [ Time Frame: Baseline; Week 12 ]
11. Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score [ Time Frame: Baseline; Week 12 ]
12. Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score [ Time Frame: Baseline; Week 12 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Florida

Sarkis Clinical Trials

Gainesville, Florida, United States, 32607

United States, Georgia

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

United States, Illinois

University of Chicago Medical Center Clinical Trial Site 2

Chicago, Illinois, United States, 60637

United States, Massachusetts

BTC of New Bedford

New Bedford, Massachusetts, United States, 01740

United States, Missouri

Psychiatric Care and Research Center

O'Fallon, Missouri, United States, 63368

United States, Nevada

Atlea Research Institute

Las Vegas, Nevada, United States, 89102

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

Manhattan Behavioral Medicine

New York, New York, United States, 10036

United States, Ohio

Research Institute Lindner Center of Hope/University of Cincinnati

Mason, Ohio, United States, 45040

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

• Responsible Party: Avanir Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03420222
• Other Study ID Numbers: 17-AVP-786-206
• First Posted: February 5, 2018
• Last Update Posted: December 24, 2019
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Avanir Pharmaceuticals:

Intermittent Explosive Disorder; AVP-786

Additional relevant MeSH terms:

Disease; Disruptive, Impulse Control, and Conduct Disorders; Pathologic Processes; Mental Disorders