Status:
TERMINATED
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Intermittent Explosive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
- 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
- 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)
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03420222
Start Date
January 18 2018
End Date
December 28 2018
Last Update
May 24 2022
Active Locations (9)
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1
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
2
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
3
University of Chicago Medical Center Clinical Trial Site 2
Chicago, Illinois, United States, 60637
4
BTC of New Bedford
New Bedford, Massachusetts, United States, 01740