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

NCT02989779 | Unknown Phase 1

• 1 other identifier: 2016-1986-GRA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aggression

Outcome Measures

Primary Outcomes (1)

• Change in Modified Overt Aggression Scale

  1 week

Secondary Outcomes (5)

• Change in Ball passing task

  1 week

• Change in Point Subtraction Aggression Task (PSAT)

  1 week

• 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

Study Arms (2)

Active/Placebo crossover

EXPERIMENTAL

NK1 Antagonist 7 days followed by placebo 7 days.

Drug: NK1 Antagonist; Drug: Placebo Oral Capsule

Placebo/Active Crossover

ACTIVE COMPARATOR

Placebo for 7 days followed by NK1 Antagonist 7 days.

Drug: NK1 Antagonist; Drug: Placebo Oral Capsule

Interventions

NK1 Antagonist DRUG

Active/Placebo crossover; Placebo/Active Crossover

Placebo Oral Capsule DRUG

Active/Placebo crossover; Placebo/Active Crossover

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N3K7, Canada

RECRUITING

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Central Study Contacts

Sheila Verhage-Brown, MD

CONTACT

905-522-1155; sverhage@stjoes.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Local Primary Investigator, Head of Forensics

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 12, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)