Aggression
Conditions
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.
Interventions
DRUGNK1 Antagonist
DRUGPlacebo Oral Capsule
Sponsors
University Health Network, Toronto
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Modified Overt Aggression Scale | 1 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Canada
Contacts
Primary ContactSheila Verhage-Brown, MD
Outcome results
None listed