This study is designed to explore the safety and tolerability, and to compare the activity of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will be randomized to either SRX246 or Placebo treatment groups. Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits throughout the trial. The study results will be determined based on any changes observed over the study period.
This exploratory Phase II study has been designed to examine the safety and tolerability profile, and to compare the activity of the novel V1a vasopressin antagonist (SRX246) against placebo, in adults with DSM-5 Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current DSM-5 diagnosis of IED will be enrolled. All subjects will undergo systematic diagnostic assessment for DSM-5 Axis I and II disorders. Subjects with DSM-5 IED (without current, co-morbid, DSM-5 Major Depression) whose: (a) Life History of Aggression (LHA) score is \> 12, (b) Overt Aggression Scale Modified (OAS-M) "Irritability" score is \> 6 and, (c) screening OAS-M "Aggression" score is \> 15, will be entered into a two-week baseline lead-in phase. After the lead-in phase, study subjects who continue to meet OAS-M criteria will be randomized to one of the two (2) treatment conditions and stratified by gender so that equal numbers of males and females are assigned to SRX246 and Placebo Groups. Those who do not meet the criteria will exit the protocol at that time. Treatment Conditions: (a) 8-week course of SRX246 (4 weeks at 120 mg bid, and 4 weeks at 160 mg bid) or (b) 8-week course of Placebo, followed by a one-week "taper" to withdraw subjects from study medication. IED subjects in all conditions will have structured diagnostic interview sessions and questionnaires administered throughout the trial. Blinding to treatment condition will be maintained by using different personnel for these activities. Analysis of a change from baseline in the diagnostic measures will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
Atlanta Center for Medical Research
Atlanta, Georgia, United States
University of Chicago, Department of Psychiatry
Chicago, Illinois, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Lindner Center of HOPE
Mason, Ohio, United States
Rhode Island Hospital, Department of Psychiatry
Providence, Rhode Island, United States
Safety and Tolerability
measured as the number of participants with adverse events
Time frame: from initial dose of intervention until completion of the study up to 8 weeks
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