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Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

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

NCT02989779•St. Joseph's Healthcare Hamilton

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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

Locations (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Key Dates

Start Date

January 1, 2017

Primary Completion Date

March 1, 2020

Completion Date

June 1, 2020

Last Updated

April 22, 2019

Enrollment

ESTIMATED participants

Conditions

Aggression

Interventions

NK1 Antagonist

DRUG

Placebo Oral Capsule

DRUG

Contacts

Sheila Verhage-Brown, MD

CONTACT

905-522-1155 sverhage@stjoes.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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