Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour (AHIMSA-1)
Primary Purpose
Aggression
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
NK1 Antagonist
Placebo Oral Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Aggression
Eligibility Criteria
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
Sites / Locations
- St. Joseph's Healthcare HamiltonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active/Placebo crossover
Placebo/Active Crossover
Arm Description
NK1 Antagonist 7 days followed by placebo 7 days.
Placebo for 7 days followed by NK1 Antagonist 7 days.
Outcomes
Primary Outcome Measures
Change in Modified Overt Aggression Scale
Secondary Outcome Measures
Change in Ball passing task
computer task
Change in Point Subtraction Aggression Task (PSAT)
Computer task
Change in Anger Disorders Scale (ADS)
Change in Buss-Perry Aggression Questionniare (BPAQ)
Change in State-Trait Anger Expression Inventory
Full Information
NCT ID
NCT02989779
First Posted
November 23, 2016
Last Updated
April 18, 2019
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02989779
Brief Title
Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour
Acronym
AHIMSA-1
Official Title
NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active/Placebo crossover
Arm Type
Experimental
Arm Description
NK1 Antagonist 7 days followed by placebo 7 days.
Arm Title
Placebo/Active Crossover
Arm Type
Active Comparator
Arm Description
Placebo for 7 days followed by NK1 Antagonist 7 days.
Intervention Type
Drug
Intervention Name(s)
NK1 Antagonist
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Primary Outcome Measure Information:
Title
Change in Modified Overt Aggression Scale
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in Ball passing task
Description
computer task
Time Frame
1 week
Title
Change in Point Subtraction Aggression Task (PSAT)
Description
Computer task
Time Frame
1 week
Title
Change in Anger Disorders Scale (ADS)
Time Frame
1 week
Title
Change in Buss-Perry Aggression Questionniare (BPAQ)
Time Frame
1 week
Title
Change in State-Trait Anger Expression Inventory
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Verhage-Brown, MD
Phone
905-522-1155
Ext
36356
Email
sverhage@stjoes.ca
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Verhage-Brown, MD
Phone
905-522-1155
Ext
36356
Email
sverhage@stjoes.ca
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.
Learn more about this trial
Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour
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