## Protocol Section
### Identification Module
**NCT ID:** NCT02989779

**Acronym:** AHIMSA-1

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

**Official Title:** NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial

#### Organization Study ID Info
**ID:** 2016-1986-GRA
#### Organization
**Class:** OTHER
**Full Name:** St. Joseph's Healthcare Hamilton
### Status Module
#### Completion Date
**Date:** 2020-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-04-22

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-01

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2016-12-12
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-23
**Study First Submit QC Date:** 2016-12-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University Health Network, Toronto

#### Lead Sponsor

**Class:** OTHER

**Name:** St. Joseph's Healthcare Hamilton

#### Responsible Party

**Investigator Affiliation:** St. Joseph's Healthcare Hamilton

**Investigator Full Name:** Gary Chaimowitz

**Investigator Title:** Local Primary Investigator, Head of Forensics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Aggression

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** NK1 Antagonist 7 days followed by placebo 7 days.

**Intervention Names:**

- Drug: NK1 Antagonist

- Drug: Placebo Oral Capsule

**Label:** Active/Placebo crossover

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo for 7 days followed by NK1 Antagonist 7 days.

**Intervention Names:**

- Drug: NK1 Antagonist

- Drug: Placebo Oral Capsule

**Label:** Placebo/Active Crossover

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active/Placebo crossover

- Placebo/Active Crossover

**Name:** NK1 Antagonist

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Active/Placebo crossover

- Placebo/Active Crossover

**Name:** Placebo Oral Capsule

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in Modified Overt Aggression Scale

**Time Frame:** 1 week

#### Secondary Outcomes

**Description:** computer task

**Measure:** Change in Ball passing task

**Time Frame:** 1 week

**Description:** Computer task

**Measure:** Change in Point Subtraction Aggression Task (PSAT)

**Time Frame:** 1 week

**Measure:** Change in Anger Disorders Scale (ADS)

**Time Frame:** 1 week

**Measure:** Change in Buss-Perry Aggression Questionniare (BPAQ)

**Time Frame:** 1 week

**Measure:** Change in State-Trait Anger Expression Inventory

**Time Frame:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sverhage@stjoes.ca

**Name:** Sheila Verhage-Brown, MD

**Phone:** 905-522-1155

**Phone Ext:** 36356

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hamilton

**Contacts:**

***Contact 1:***

- **Email:** sverhage@stjoes.ca

- **Name:** Sheila Verhage-Brown, MD

- **Phone:** 905-522-1155

- **Phone Ext:** 36356

- **Role:** CONTACT

**Country:** Canada

**Facility:** St. Joseph's Healthcare Hamilton

**State:** Ontario

**Status:** RECRUITING

**Zip:** L8N3K7

### IPD Sharing Statement Module

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

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000096762

- Term: Aberrant Motor Behavior in Dementia

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10220

- Name: Impulsive Behavior

- Relevance: LOW

- As Found: Unknown

- ID: M3724

- Name: Aggression

- Relevance: HIGH

- As Found: Aggression

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M3259

- Name: Aberrant Motor Behavior in Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000374

- Term: Aggression

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17988

- Name: Neurokinin A

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
