By mid-August Lindner Center of HOPE researchers anticipate recruiting for a new medication trial that could impact the treatment of Intermittent Explosive Disorder (IED). IED, characterized by an inability to resist aggressive urges and explosive outbursts, affects six percent of the general population with no designated medications currently available for treatment.
The exploratory Phase II study, expected to begin in mid to late August, has been designed to examine the efficacy, safety and tolerability profile of the novel V1a vasopressin antagonist (SRX246) against placebo, in adults meeting the DSM-5 (Diagnostic and Statistical Manual) criteria for IED. A large body of translational research indicates that blocking the vasopressin (V1a) receptor might be a plausible form of treatment. Studies have found that vasopressin (V1a) has an established role in signaling social and emotional behavior, including aggression.
DSM-5 criteria for IED defines it as recurrent behavioral outbursts representing a failure to control aggressive impulses as manifested by either:
- Verbal aggression or physical aggression toward property, animals or other individuals, occurring, on average, twice weekly for a period of three months. The physical aggression does not result in damage or destruction of property and does not result in physical injury to animals or other individuals.
- Three behavioral outbursts involving damage or destruction of property and/or physical assault with physical injury against animals or other individuals occurring within a 12-month period.
The behavior is distressing for the individual and is not premeditated and not due to another psychiatric illness.
“This disorder comes with lots of complications,” according to Dr. Susan McElroy, Chief Research Officer, Lindner Center of HOPE. “Often we see individuals struggling with IED facing legal problems, social issues, marital difficulties, child abuse concerns, medical problems from injuries sustained during the physical outbursts, significant distress, severe psychosocial complications and even loss of employment.”
“The potential for gaining control over IED with medication would be incredibly beneficial for those struggling.”
The clinical trial is seeking to recruit males and females age 18 to 55 with moderate IED. Candidates with substance abuse disorders, compromised medical health or currently taking psychotropic medications will not be eligible to participate. Those meeting criteria should expect to participate in 8 weeks of treatment.
If interested in participating in the trial, contact 513-536-0710.