Clinical trial NCT02989779: Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour
Official title: NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Aggression
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2016-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Modified Overt Aggression Scale
timeFrame: 1 week
Secondary outcomes:
measure: Change in Ball passing task
timeFrame: 1 week
measure: Change in Point Subtraction Aggression Task (PSAT)
timeFrame: 1 week
measure: Change in Anger Disorders Scale (ADS)
timeFrame: 1 week
measure: Change in Buss-Perry Aggression Questionniare (BPAQ)
timeFrame: 1 week
measure: Change in State-Trait Anger Expression Inventory
timeFrame: 1 week
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References: