Intermittent Explosive DisorderPhase 1/2AVN009NCT02055638
Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder
A Phase 1/2 study testing SRX246 in people with Intermittent Explosive Disorder, run by Azevan Pharmaceuticals at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Intermittent Explosive Disorder
- What is being tested?
- SRX246
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2014to May 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
University of Chicago, Department of Psychiatry
Chicago, Illinois, 60637
Lindner Center of HOPE
Mason, Ohio, 45040
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Rhode Island Hospital, Department of Psychiatry
Providence, Rhode Island, 02903
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Intermittent Explosive Disorder
- Being tested
- SRX246, Placebo
- Keywords
- Intermittent Explosive Disorder, IED, Aggression, SRX246, Vasopressin 1a Receptor Antagonist, V1a
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRX246Drug
capsules
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SRX246 | Experimental | SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks Receives: Drug: SRX246 |
| Placebo | Placebo comparator | Placebo capsules to match the amount of SRX246 capsules for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
measured as the number of participants with adverse events
Measured: from initial dose of intervention until completion of the study up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intermittent Explosive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azevan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055638
- Sponsor's protocol ID
- AVN009
- Acronym
- AVN009
- Status last verified
- Jul 2023
- First submitted
- 3 Feb 2014
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02055638
- Acronym / sponsor ID
- AVN009 / AVN009
- Conditions
- Intermittent Explosive Disorder
- Keywords
- Intermittent Explosive Disorder, IED, Aggression, SRX246, Vasopressin 1a Receptor Antagonist, V1a
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Azevan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Posted 29 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRX246 | Experimental | Drug: SRX246SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules to match the amount of SRX246 capsules for 8 weeks |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRX246capsules | Drug | SRX246 |
| Placebo | Drug | Placebo |
Primary outcome
Safety and Tolerability
Time frame: from initial dose of intervention until completion of the study up to 8 weeks
measured as the number of participants with adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SRX246 in people with Intermittent Explosive Disorder, run by Azevan Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: from initial dose of intervention until completion of the study up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.