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Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03420222
Recruitment Status : Terminated (Business Reasons (No safety concerns))
First Posted : February 5, 2018
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).

Condition or disease Intervention/treatment Phase
Intermittent Explosive Disorder Drug: AVP-786 Drug: Placebo Phase 2

Detailed Description:

Eligible participants for this study must have a diagnosis of current IED.

This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 28, 2018
Actual Study Completion Date : December 28, 2018

Arm Intervention/treatment
Experimental: AVP-786
Dose 1 capsules administered twice a day over a 12-week period
Drug: AVP-786
oral capsules

Placebo Comparator: Placebo
Placebo capsules administered twice a day over a 12-week period
Drug: Placebo
oral capsules




Primary Outcome Measures :
  1. Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score [ Time Frame: Baseline; Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in the OAS-M Total Irritability Score [ Time Frame: Baseline; Week 12 ]
  2. Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability [ Time Frame: Baseline; Week 12 ]
  3. Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days [ Time Frame: Baseline; Week 12 ]
  4. Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary [ Time Frame: Baseline; Week 12 ]
  5. Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes [ Time Frame: Baseline; Week 12 ]
  6. Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED [ Time Frame: Baseline; Week 12 ]
  7. Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED [ Time Frame: Baseline; Week 12 ]
  8. Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED [ Time Frame: Baseline; Week 12 ]
  9. Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED [ Time Frame: Baseline; Week 12 ]
  10. Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score [ Time Frame: Baseline; Week 12 ]
  11. Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score [ Time Frame: Baseline; Week 12 ]
  12. Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score [ Time Frame: Baseline; Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)
  • At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
  • Score ≥ 12 on the Life History of Aggression scale at screening
  • Score ≥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline
  • Score ≥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline

Exclusion Criteria:

  • Diagnosis of major depressive disorder within 6 months of screening
  • Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 at screening
  • Met only the DSM-5 A2 criterion for IED
  • Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
  • Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420222


Locations
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United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, Illinois
University of Chicago Medical Center Clinical Trial Site 2
Chicago, Illinois, United States, 60637
United States, Massachusetts
BTC of New Bedford
New Bedford, Massachusetts, United States, 01740
United States, Missouri
Psychiatric Care and Research Center
O'Fallon, Missouri, United States, 63368
United States, Nevada
Atlea Research Institute
Las Vegas, Nevada, United States, 89102
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Manhattan Behavioral Medicine
New York, New York, United States, 10036
United States, Ohio
Research Institute Lindner Center of Hope/University of Cincinnati
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Avanir Pharmaceuticals
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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03420222    
Other Study ID Numbers: 17-AVP-786-206
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avanir Pharmaceuticals:
Intermittent Explosive Disorder
AVP-786
Additional relevant MeSH terms:
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Disease
Disruptive, Impulse Control, and Conduct Disorders
Pathologic Processes
Mental Disorders