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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aggression

Intervention / Treatment
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* Drug: NK1 Antagonist
* Drug: Placebo Oral Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |