AggressionPhase 1/2AHIMSA-1NCT02989779
Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour
A Phase 1/2 study testing NK1 Antagonist in people with Aggression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aggression
- What is being tested?
- NK1 Antagonist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jun 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N3K7
Sheila Verhage-Brown, MD, 905-522-1155 ext. 36356, sverhage@stjoes.ca
About this study
Official title: NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial
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
- Aggression
- Being tested
- NK1 Antagonist, Placebo Oral Capsule
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK1 AntagonistDrug
Placebo Oral CapsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Active/Placebo crossover | Experimental | NK1 Antagonist 7 days followed by placebo 7 days. Receives: Drug: NK1 Antagonist; Drug: Placebo Oral Capsule |
| Placebo/Active Crossover | Active comparator | Placebo for 7 days followed by NK1 Antagonist 7 days. Receives: Drug: NK1 Antagonist; Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Overt Aggression Scale
Measured: 1 week
Secondary outcomes (5)
Change in Ball passing task
computer task
Measured: 1 week
Change in Point Subtraction Aggression Task (PSAT)
Computer task
Measured: 1 week
Change in Anger Disorders Scale (ADS)
Measured: 1 week
Change in Buss-Perry Aggression Questionniare (BPAQ)
Measured: 1 week
Change in State-Trait Anger Expression Inventory
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Gary Chaimowitz, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989779
- Sponsor's protocol ID
- 2016-1986-GRA
- Acronym
- AHIMSA-1
- Status last verified
- Apr 2019
- First submitted
- 23 Nov 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial
- ClinicalTrials.gov ID
- NCT02989779
- Acronym / sponsor ID
- AHIMSA-1 / 2016-1986-GRA
- Conditions
- Aggression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Jan 2017
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active/Placebo crossover | Experimental | Drug: NK1 Antagonist, Drug: Placebo Oral CapsuleNK1 Antagonist 7 days followed by placebo 7 days. |
| Placebo/Active Crossover | Active comparator | Drug: NK1 Antagonist, Drug: Placebo Oral CapsulePlacebo for 7 days followed by NK1 Antagonist 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK1 Antagonist | Drug | Active/Placebo crossover, Placebo/Active Crossover |
| Placebo Oral Capsule | Drug | Active/Placebo crossover, Placebo/Active Crossover |
Primary outcome
Change in Modified Overt Aggression Scale
Time frame: 1 week
5 secondary outcomes
Change in Ball passing task
Time frame: 1 week
Change in Point Subtraction Aggression Task (PSAT)
Time frame: 1 week
Change in Anger Disorders Scale (ADS)
Time frame: 1 week
Change in Buss-Perry Aggression Questionniare (BPAQ)
Time frame: 1 week
Change in State-Trait Anger Expression Inventory
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: Yes. De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NK1 Antagonist in people with Aggression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila Verhage-Brown, MD (905-522-1155 ext. 36356, sverhage@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Overt Aggression Scale (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.