Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder (AVN009)
|ClinicalTrials.gov Identifier: NCT02055638|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : June 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Explosive Disorder||Drug: SRX246 Drug: Placebo||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An Exploratory Phase II Study to Determine the Safety, Tolerability and Activity of a Novel Vasopressin 1a Receptor Antagonist (SRX246) in Adults With Diagnostic and Statistical Manual Version 5 (DSM-5) Intermittent Explosive Disorder (IED)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks
Placebo Comparator: Placebo
Placebo capsules to match the amount of SRX246 capsules for 8 weeks
- safety and tolerability [ Time Frame: weekly up to 8 weeks ]physical exam, vital signs, electrocardiogram, hematology, serum chemistry, urinalysis, adverse event (AE)/serious adverse event (SAE) reports
- Reduction in Total Aggression Score [ Time Frame: weekly up to 8 weeks ]Determine the activity of SRX246 in reducing aggression in IED patients using diagnostic questionnaires and interview sessions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055638
|United States, Georgia|
|Atlanta Center for Medical Research|
|Atlanta, Georgia, United States, 30331|
|United States, Illinois|
|University of Chicago, Department of Psychiatry|
|Chicago, Illinois, United States, 60637|
|United States, Missouri|
|Psychiatric Care and Research Center|
|O'Fallon, Missouri, United States, 63368|
|United States, New York|
|SPRI Clinical Trials, LLC|
|Brooklyn, New York, United States, 11235|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|United States, Ohio|
|Lindner Center of HOPE|
|Mason, Ohio, United States, 45040|
|United States, Rhode Island|
|Rhode Island Hospital, Department of Psychiatry|
|Providence, Rhode Island, United States, 02903|