Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder

Exclusion Criteria

• •Subject with a positive test for alcohol and/or drugs of abuse at screening or at any time during the study.
• •Presence of any of the following serious and active medical conditions: Seizure Disorder (n.b.: history of \< 2 febrile seizures prior to one year of age is acceptable); Demyelinating or Progressive Degenerative Disorders; central nervous system (CNS) Infection; Progressive Degenerative Neurological Disorder; Ischemic Heart Disease, Respiratory Disease, Renal Disease; Liver Disease; Type I Diabetes; Malignant Neoplasm; Hyper- or Hypo-Coagulopathy; Acquired Immuno-Deficiency Syndrome (AIDS).
• •Routine or as needed consumption of medications or herbal supplements that the subject is unable or unwilling to discontinue during the study.
• •Other ongoing psychotherapeutic treatment for the treatment of IED or anger begun less than three months before entry into this study.
• •Not Current DSM-5 IED.
• •LHA score \< 12 at Visit 1 (screen).
• •OAS-M Irritability score \< 6 or OAS-M Total Aggression score \< 15 at Visit 1 (screen).
• •Current major depressive episode or life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation.
• •Current DSM-5 Substance Use Disorder of moderate or greater severity (i.e., ≥ 4 Substance Use Disorder (SUD) symptoms).
• •Active suicidal ideation as determined by clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).
• •Evidence of any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Study Investigator.
• •A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis), or any known/suspected hypersensitivity to SRX246.
• •A general medical or psychological condition or behavior, including current substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent.
• •Unwilling/unable to sign informed consent document.
• •Any clinically significant abnormality on screening resting 12-lead EKG (e.g., heart block, conduction disorders, ventricular and/or atrial arrhythmias).
• •Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Study Investigator, would make the subject unsuitable for the study or put them at additional risk.
• •Inability to understand or follow study instructions.
• •Treatment with an investigational drug within 30 days preceding the first dose of study medication.
• •Women who are currently breastfeeding and/or lactating.