Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermitte… (NCT03420222) | Clinical Trial Compass
TerminatedPhase 2
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
Stopped: Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.
United States10 participantsStarted 2018-01-18
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).
Who can participate
Age range18 Years – 65 Years
SexALL
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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)
What they're measuring
1
Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
Timeframe: Baseline; Week 12
Trial details
NCT IDNCT03420222
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.