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

Aggression Clinical Trial

— AHIMSA-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989779
• Other study ID #: 2016-1986-GRA
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2017
• Est. completion date: June 2020

Study information

• Verified date: April 2019
• Source: St. Joseph's Healthcare Hamilton
• Contact: Sheila Verhage-Brown, MD
• Phone: 905-522-1155
• Email: sverhage[@]stjoes.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression

Intervention

Drug:
• NK1 Antagonist

• Placebo Oral Capsule

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Overt Aggression Scale		1 week
Secondary	Change in Ball passing task	computer task	1 week
Secondary	Change in Point Subtraction Aggression Task (PSAT)	Computer task	1 week
Secondary	Change in Anger Disorders Scale (ADS)		1 week
Secondary	Change in Buss-Perry Aggression Questionniare (BPAQ)		1 week
Secondary	Change in State-Trait Anger Expression Inventory		1 week