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

Phase 1

• Conditions: Aggression
• Interventions: Drug: NK1 Antagonist; Drug: Placebo Oral Capsule

• Registration Number: NCT02989779
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-12
• Study Start: 2017-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-22
• Primary Completion: 2020-03
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active/Placebo crossover	NK1 Antagonist	NK1 Antagonist 7 days followed by placebo 7 days.
Active/Placebo crossover	Placebo Oral Capsule	NK1 Antagonist 7 days followed by placebo 7 days.
Placebo/Active Crossover	NK1 Antagonist	Placebo for 7 days followed by NK1 Antagonist 7 days.
Placebo/Active Crossover	Placebo Oral Capsule	Placebo for 7 days followed by NK1 Antagonist 7 days.

Primary Outcome Measures

Name	Time	Method
Change in Modified Overt Aggression Scale	1 week

Secondary Outcome Measures

Name	Time	Method
Change in Ball passing task	1 week	computer task
Change in Point Subtraction Aggression Task (PSAT)	1 week	Computer task
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

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada