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

NCT02055638 | Completed Phase 1 Results

• 1 other identifier: AVN009
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Intermittent Explosive Disorder

Keywords

Intermittent Explosive Disorder; IED; Aggression; SRX246; Vasopressin 1a Receptor Antagonist; V1a

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  measured as the number of participants with adverse events

  from initial dose of intervention until completion of the study up to 8 weeks

Other Outcomes (1)

• Overt Aggression Scale Modified (OAS-M) Total Aggression Score

  Comparison of baseline score to score at end of treatment period of 8 weeks

Study Arms (2)

SRX246

EXPERIMENTAL

SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks

Drug: SRX246

Placebo

PLACEBO COMPARATOR

Placebo capsules to match the amount of SRX246 capsules for 8 weeks

Drug: Placebo

Interventions

SRX246 DRUG

capsules

SRX246

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female (Women of child bearing potential must be non-pregnant, non-lactating and agree to be on an acceptable method of contraception.)
• Age 21 to 55 years, inclusive.
• In good general physical health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (EKG) measurement.
• Current IED by DSM-5
• LHA-Aggression ≥ 12.
• OAS-M Irritability score ≥ 6, and OAS-M Total Aggression score ≥ 15, respectively at Visit 1
• Mean Irritability and Total Aggression scores for Visit 2 and Visit 3, ≥ 6 and ≥ 15, respectively.
• Subject is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
• Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azevan Pharmaceuticals: lead

Study Sites (7)

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

University of Chicago, Department of Psychiatry

Chicago, Illinois, 60637, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Rhode Island Hospital, Department of Psychiatry

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders; Aggression

Interventions

SRX246

Condition Hierarchy (Ancestors)

Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Results Point of Contact

• Title: Dr. Neal Simon, CEO
• Organization: Azevan Pharmaceuticals, Inc.

ngsimon@azevan.com

(610) 419-1057

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 5, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 21, 2023
• Results First Posted: October 29, 2019

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)