Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour (AHIMSA-1)

NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial

Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and Modified Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI before the trial begins. Patients receive either one week of the drug or one week of placebo and perform the same tasks and assessments. Then patients receive another week of the alternate pill, followed by another round of tasks during MRI and assessments.

Study Overview

• Status: Unknown
• Conditions: Aggression
• Intervention / Treatment: Drug: NK1 Antagonist; Drug: Placebo Oral Capsule

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3K7
      • Recruiting
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• are outpatients between 18 and 65 years old inclusive
• meet diagnostic criteria for either Intermittent Explosive Disorder or the adult-modified criteria for Disruptive Mood Dysregulation Disorder (Appendix A)
• have maintained a stable regimen of psychotropic medications (antidepressants, antipsychotics, anticonvulsants, and anxiolytics) for at least 4 weeks prior to study enrolment and throughout the duration of the treatment phase of the study
• If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
• Have capacity with respect to medical decision-making and consent to participate
• pass the TMS Assessment Safety Survey (TASS) MRI safety questionnaire

Exclusion Criteria:

• have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or other primary psychotic disorder
• meet criteria for a current manic episode or hypomanic episode
• have a diagnosis of dementia or other neurodegenerative illness affecting the central nervous system
• have a history of substance dependence or abuse within the last 3 months

• are pregnant or currently nursing*

  • *Patients will be tested before and after the study with a urine pregnancy test.
• are taking contraindicated or interacting medications from product monograph of aprepitant
• have an implanted intracranial device or pacemaker
• have a diagnosis of severe hepatic insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active/Placebo crossover; NK1 Antagonist 7 days followed by placebo 7 days.	Drug: NK1 Antagonist; Drug: Placebo Oral Capsule
Active Comparator: Placebo/Active Crossover; Placebo for 7 days followed by NK1 Antagonist 7 days.	Drug: NK1 Antagonist; Drug: Placebo Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Modified Overt Aggression Scale	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ball passing task	computer task	1 week
Change in Point Subtraction Aggression Task (PSAT)	Computer task	1 week
Change in Anger Disorders Scale (ADS)		1 week
Change in Buss-Perry Aggression Questionniare (BPAQ)		1 week
Change in State-Trait Anger Expression Inventory		1 week

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: 2016-1986-GRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No