Clinical trial NCT03420222: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Intermittent Explosive Disorder
Keywords: Intermittent Explosive Disorder
AVP-786
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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
* 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)

Primary outcomes:
measure: Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Change From Baseline in the OAS-M Total Irritability Score at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the OAS-M Individual Items for Aggression at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the OAS-M Individual Items for Irritability at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Number of IED Episodes at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Severity of IED Episodes at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Severity of Distress From Episodes at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12
timeFrame: Baseline; Week 12
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center Clinical Trial Site 2
state: Illinois
city: New Bedford
country: United States
facility: BTC of New Bedford
state: Massachusetts
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Las Vegas
country: United States
facility: Atlea Research Institute
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Mason
country: United States
facility: Research Institute Lindner Center of Hope/University of Cincinnati
state: Ohio
Study officials:
References: