CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
SRX246 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02055638
NCT02055638Phase 2Completed

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)

Azevan Pharmaceuticals·interventional·Posted Feb 5, 2014·Updated Jul 21, 2023

In Brief

A Phase 2 clinical trial evaluating SRX246 and Placebo for Intermittent Explosive Disorder. Completed, enrolled 97 participants across 7 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2014
Enrollment StartMay 1, 2014
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.4 years ago

Interventions

SRX246drug

capsules

Placebodrug