<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989779</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1986-GRA</org_study_id>
    <nct_id>NCT02989779</nct_id>
  </id_info>
  <brief_title>Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour</brief_title>
  <acronym>AHIMSA-1</acronym>
  <official_title>NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind&#xD;
      placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and Modified&#xD;
      Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI before the&#xD;
      trial begins. Patients receive either one week of the drug or one week of placebo and perform&#xD;
      the same tasks and assessments. Then patients receive another week of the alternate pill,&#xD;
      followed by another round of tasks during MRI and assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Modified Overt Aggression Scale</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Ball passing task</measure>
    <time_frame>1 week</time_frame>
    <description>computer task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Point Subtraction Aggression Task (PSAT)</measure>
    <time_frame>1 week</time_frame>
    <description>Computer task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anger Disorders Scale (ADS)</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Buss-Perry Aggression Questionniare (BPAQ)</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in State-Trait Anger Expression Inventory</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Aggression</condition>
  <arm_group>
    <arm_group_label>Active/Placebo crossover</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NK1 Antagonist 7 days followed by placebo 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/Active Crossover</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo for 7 days followed by NK1 Antagonist 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NK1 Antagonist</intervention_name>
    <arm_group_label>Active/Placebo crossover</arm_group_label>
    <arm_group_label>Placebo/Active Crossover</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <arm_group_label>Active/Placebo crossover</arm_group_label>
    <arm_group_label>Placebo/Active Crossover</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  are outpatients between 18 and 65 years old inclusive&#xD;
&#xD;
          -  meet diagnostic criteria for either Intermittent Explosive Disorder or the&#xD;
             adult-modified criteria for Disruptive Mood Dysregulation Disorder (Appendix A)&#xD;
&#xD;
          -  have maintained a stable regimen of psychotropic medications (antidepressants,&#xD;
             antipsychotics, anticonvulsants, and anxiolytics) for at least 4 weeks prior to study&#xD;
             enrolment and throughout the duration of the treatment phase of the study&#xD;
&#xD;
          -  If participating in psychotherapy, must have been in stable treatment for at least 3&#xD;
             months prior to entry into the study, with no anticipation of change in the frequency&#xD;
             of therapeutic sessions, or the therapeutic focus over the duration of the study&#xD;
&#xD;
          -  Have capacity with respect to medical decision-making and consent to participate&#xD;
&#xD;
          -  pass the TMS Assessment Safety Survey (TASS) MRI safety questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform&#xD;
             disorder, delusional disorder, or other primary psychotic disorder&#xD;
&#xD;
          -  meet criteria for a current manic episode or hypomanic episode&#xD;
&#xD;
          -  have a diagnosis of dementia or other neurodegenerative illness affecting the central&#xD;
             nervous system&#xD;
&#xD;
          -  have a history of substance dependence or abuse within the last 3 months&#xD;
&#xD;
          -  are pregnant or currently nursing*&#xD;
&#xD;
               -  *Patients will be tested before and after the study with a urine pregnancy test.&#xD;
&#xD;
          -  are taking contraindicated or interacting medications from product monograph of&#xD;
             aprepitant&#xD;
&#xD;
          -  have an implanted intracranial device or pacemaker&#xD;
&#xD;
          -  have a diagnosis of severe hepatic insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sheila Verhage-Brown, MD</last_name>
    <phone>905-522-1155</phone>
    <phone_ext>36356</phone_ext>
    <email>sverhage@stjoes.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheila Verhage-Brown, MD</last_name>
      <phone>905-522-1155</phone>
      <phone_ext>36356</phone_ext>
      <email>sverhage@stjoes.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Gary Chaimowitz</investigator_full_name>
    <investigator_title>Local Primary Investigator, Head of Forensics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989779
org study id: 2016-1986-GRA
nct id: NCT02989779
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Modified Overt Aggression Scale
time frame: 1 week
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
description: Computer task
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
arm group label: Active/Placebo crossover
arm group type: Experimental
description: NK1 Antagonist 7 days followed by placebo 7 days.
arm group label: Placebo/Active Crossover
arm group type: Active Comparator
description: Placebo for 7 days followed by NK1 Antagonist 7 days.
intervention type: Drug
intervention name: NK1 Antagonist
arm group label: Active/Placebo crossover
arm group label: Placebo/Active Crossover
intervention type: Drug
intervention name: Placebo Oral Capsule
arm group label: Active/Placebo crossover
arm group label: Placebo/Active Crossover
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sheila Verhage-Brown, MD
phone: 905-522-1155
phone ext: 36356
email: sverhage@stjoes.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Gary Chaimowitz
investigator title: Local Primary Investigator, Head of Forensics
mesh term: Aggression
sharing ipd: Yes
ipd description: De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.