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

St. Joseph's Healthcare Hamilton

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Aggression

Treatments: Drug: Placebo Oral Capsule; Drug: NK1 Antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT02989779

2016-1986-GRA

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Active/Placebo crossover

Experimental group

Description:

NK1 Antagonist 7 days followed by placebo 7 days.

Treatment:

Drug: Placebo Oral Capsule

Drug: NK1 Antagonist

Placebo/Active Crossover

Active Comparator group

Description:

Placebo for 7 days followed by NK1 Antagonist 7 days.

Treatment:

Drug: Placebo Oral Capsule

Drug: NK1 Antagonist