Neurokinin (NK) 1 Antagonist for Pathological Aggression... | NCT02989779

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

NCT02989779

Sponsor

St. Joseph's Healthcare Hamilton

Status

Unknown status

Last Update Posted

Apr 22, 2019Actual

Enrollment

50Estimated

Phase

Phase 1Phase 2

Conditions

Aggression

Interventions

NK1 Antagonist
Placebo Oral Capsule

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Mar 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Dec 8, 2016

First Posted Date

Dec 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2019

Last Update Posted Date

Apr 22, 2019Actual

Name	Class
University Health Network, Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NK1 Antagonist	Drug		Active/Placebo crossover Placebo/Active Crossover
Placebo Oral Capsule

Measure	Description	Time Frame
Change in Modified Overt Aggression Scale		1 week

Measure	Description	Time Frame
Change in Ball passing task	computer task	1 week
Change in Point Subtraction Aggression Task (PSAT)	Computer task	1 week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Sheila Verhage-Brown, MD	Contact	905-522-1155	36356	sverhage@stjoes.ca

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Healthcare Hamilton	Recruiting	Hamilton	Ontario	L8N3K7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000096762	Aberrant Motor Behavior in Dementia
D001526	Behavioral Symptoms
D001519	Behavior
D012919	Social Behavior