Recruiting
Phase 1
Phase 2

NK1 Antagonist

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT02989779

Conditions

Aggression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

NK1 Antagonist

Placebo Oral Capsule

Study Details

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

Study ID

NCT02989779

Start date

Jan, 2017

Status verified date

Apr, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active/Placebo crossover

NK1 Antagonist 7 days followed by placebo 7 days.

active comparator: Placebo/Active Crossover

Placebo for 7 days followed by NK1 Antagonist 7 days.

Interventions

NK1 Antagonist

Placebo Oral Capsule

Primary outcome measure

  • Change in Modified Overt Aggression Scale [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Sheila Verhage-Brown, MD

905-522-1155sverhage@stjoes.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N3K7

Contacts

Sheila Verhage-Brown, MD

905-522-1155sverhage@stjoes.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Apr 22, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2019-04-22.