Depressive Disorder, MajorEarly Phase 1NCT04099771
Ketamine for Mood Disorders With Suicidal Ideation
A Early Phase 1 study testing Ketamine in people with Depressive Disorder, Major and Suicidal Ideation, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study will explore whether the use of a medication, Ketamine, can help patients who come to the ER with thoughts of suicide by improving their mood and reducing thoughts of suicide. Ketamine has been used for this purpose in patients who have been hospitalized, but it has not been well studied in the ER. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major, Suicidal Ideation
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2021
- Phase
- Early Phase 1
- 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
- English speaking
- between 18 and 65 years of age
- have active suicidal ideation as determined by psychiatry staff
- are being admitted to psychiatry under voluntary certification and are able to provide informed consent.
Who cannot join
- have been previously enrolled in the trial
- are pregnant or breastfeeding; have a known or suspected allergy to ketamine; have used ketamine within 24h of presentation
- require antipsychotics (prescription or PRN by ED staff) or ED administration of other mood-altering medications for the management of acute agitation
- have known renal or liver failure; have neurologic, respiratory, or hemodynamic compromise as determined by the treating ED physician
- have history of stroke or cardiac disease (prior MI, cardiac stents or bypass surgery); or are incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Miriam Hospital
Providence, Rhode Island, 02905
Principal Investigator
Francesca Beaudoin, MD PhD
About this study
Official title: Low Dose Ketamine for Acute Management of Mood Disorders With Suicidal Ideation
This study will explore whether the use of a medication, Ketamine, can help patients who come to the ER with thoughts of suicide by improving their mood and reducing thoughts of suicide. Ketamine has been used for this purpose in patients who have been hospitalized, but it has not been well studied in the ER. The investigators are first trying to show that patients and doctors in the ER find the treatment acceptable. The investigators also hope to determine whether Ketamine is effective in decreasing the severity of patient's suicidal thinking while in the ER. If this treatment works, future studies will look at whether it can help patients be discharged from the hospital earlier.
Research Procedures: Patients will be enrolled into the study on a voluntary basis after the research assistant has fully explained all the risks and benefits of the study (informed consent). Research assistants, Emergency Department staff, and the Psychiatry team will help identify patients for the study. Patients will be asked to complete surveys measuring the degree of their suicidal thinking and mood. Additional information will be collected on patients such as their demographics, current medications, and medical problems. Patients in the study will receive the medication, Ketamine, which will be given through an intravenous catheter (IV) at a dose based on the patient's weight and slowly infused over 40 minutes. Patients will be monitored during their stay in the Emergency Department by Emergency Department physicians and nurses for any signs of side effects to the medication. Patients will be asked to complete several surveys at specific time periods after the administration of Ketamine. All patients in the study will receive usual psychiatric care in addition to the study medication.
Read the detailed description
Mood disorders complicated by suicidal ideation (SI) are common among patients presenting to the Emergency Department (ED). Under current standard practice, patients awaiting psychiatric evaluation in the emergency department do not typically receive interventions to address their mood disorder or SI. With no end to the extended ED boarding of psychiatric patients in sight, improvements in the acute treatment of SI with ketamine may help more patients receive prompt and appropriate treatment. Low-dose ketamine has been well studied in psychiatric literature. Studies involving a single dose of ketamine are promising, demonstrating both immediate and sustained reductions in suicidal ideations. Low dose ketamine has been well-studied in the ED for pain, asthma, and agitation, but not mood disorders or SI.
This study aims to determine whether or not it is feasible to administer low dose ketamine in the emergency department for the management of mood disorders with SI. Feasibility of ketamine administration in the ED and will be determined by: (1) ability to recruit participants, (2) tolerability of the intervention, and (3) acceptability by patients/providers. The investigators will also explore whether the administration of ketamine results in improvements in mood and SI.
This prospective open label feasibility pilot study will enroll 20 participants to receive ketamine at 0.5mg/kg infused intravenously over 40 minutes. Patients that have active suicidal ideation as determined by psychiatry staff who are being admitted to psychiatry under voluntary certification will be eligible for the study. The investigators will assess self-reported mood and suicidal ideations pre- and post-infusion of ketamine. Participants will complete assessments at baseline (pre-infusion), 2 hours and 6 hours post-infusion, and daily while in the ED until inpatient disposition.
The investigators hypothesize ketamine administration will be feasible in the emergency department and will result in improved mood and decreased SI.
- Conditions
- Depressive Disorder, Major, Suicidal Ideation
- Being tested
- Ketamine
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | A total of 20 patients identified as having suicidal ideation will receive ketamine at 0.5mg/kg infused intravenously over 40 minutes. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Rate of Participants Recruited into the Study throughout study period
The study will be considered feasible if the investigators are able to successfully enroll twenty participants into the study over a one year period (~1 - 2 participants per month).
Measured: One year
Completion of total infusion of ketamine by participants
The study will be considered feasible if the intervention is tolerable to participants with no more than 25% of enrolled participants stopping the infusion of ketamine because of side effects (i.e., early stopping).
Measured: One year
Percentage of participants and providers with positive response to ketamine administration
The study will be considered feasible if the intervention is considered acceptable to patients and providers (75% positive response on acceptability questionnaires).
Measured: One year
Secondary outcomes (1)
Reduction of SI in mood disorders by ketamine
The investigators will assess effectiveness based on changes in self-reported mood and suicidal ideations pre- and post-infusion of ketamine. Participants will complete assessments at baseline (pre-infusion), 2 hours and 6 hours post-infusion, and daily while in the ED until inpatient disposition. The investigators will use the assessments inherent rating scales to determine the reduction in SI, depression, or change in mood and determine if there was a significant decrease in SI in mood disorders after ketamine administration.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Beaudoin, MD PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099771
- Sponsor's protocol ID
- 1348833
- Status last verified
- Sep 2020
- First submitted
- 14 Jun 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Ketamine for Acute Management of Mood Disorders With Suicidal Ideation
- ClinicalTrials.gov ID
- NCT04099771
- Acronym / sponsor ID
- 1348833
- Conditions
- Depressive Disorder, Major, Suicidal Ideation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Sep 2019 (actual)
- 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.
This study will explore whether the use of a medication, Ketamine, can help patients who come to the ER with thoughts of suicide by improving their mood and reducing thoughts of suicide. Ketamine has been used for this purpose in patients who have been hospitalized, but it has not been well studied in the ER. The investigators are first trying to show that patients and doctors in the ER find the treatment acceptable. The investigators also hope to determine whether Ketamine is effective in decreasing the severity of patient's suicidal thinking while in the ER. If this treatment works, future studies will look at whether it can help patients be discharged from the hospital earlier.
Research Procedures: Patients will be enrolled into the study on a voluntary basis after the research assistant has fully explained all the risks and benefits of the study (informed consent). Research assistants, Emergency Department staff, and the Psychiatry team will help identify patients for the study. Patients will be asked to complete surveys measuring the degree of their suicidal thinking and mood. Additional information will be collected on patients such as their demographics, current medications, and medical problems. Patients in the study will receive the medication, Ketamine, which will be given through an intravenous catheter (IV) at a dose based on the patient's weight and slowly infused over 40 minutes. Patients will be monitored during their stay in the Emergency Department by Emergency Department physicians and nurses for any signs of side effects to the medication. Patients will be asked to complete several surveys at specific time periods after the administration of Ketamine. All patients in the study will receive usual psychiatric care in addition to the study medication.
Detailed description
Mood disorders complicated by suicidal ideation (SI) are common among patients presenting to the Emergency Department (ED). Under current standard practice, patients awaiting psychiatric evaluation in the emergency department do not typically receive interventions to address their mood disorder or SI. With no end to the extended ED boarding of psychiatric patients in sight, improvements in the acute treatment of SI with ketamine may help more patients receive prompt and appropriate treatment. Low-dose ketamine has been well studied in psychiatric literature. Studies involving a single dose of ketamine are promising, demonstrating both immediate and sustained reductions in suicidal ideations. Low dose ketamine has been well-studied in the ED for pain, asthma, and agitation, but not mood disorders or SI.
This study aims to determine whether or not it is feasible to administer low dose ketamine in the emergency department for the management of mood disorders with SI. Feasibility of ketamine administration in the ED and will be determined by: (1) ability to recruit participants, (2) tolerability of the intervention, and (3) acceptability by patients/providers. The investigators will also explore whether the administration of ketamine results in improvements in mood and SI.
This prospective open label feasibility pilot study will enroll 20 participants to receive ketamine at 0.5mg/kg infused intravenously over 40 minutes. Patients that have active suicidal ideation as determined by psychiatry staff who are being admitted to psychiatry under voluntary certification will be eligible for the study. The investigators will assess self-reported mood and suicidal ideations pre- and post-infusion of ketamine. Participants will complete assessments at baseline (pre-infusion), 2 hours and 6 hours post-infusion, and daily while in the ED until inpatient disposition.
The investigators hypothesize ketamine administration will be feasible in the emergency department and will result in improved mood and decreased SI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineA total of 20 patients identified as having suicidal ideation will receive ketamine at 0.5mg/kg infused intravenously over 40 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- between 18 and 65 years of age
- have active suicidal ideation as determined by psychiatry staff
- are being admitted to psychiatry under voluntary certification and are able to provide informed consent.
Key exclusion criteria (5 listed)
- have been previously enrolled in the trial
- are pregnant or breastfeeding; have a known or suspected allergy to ketamine; have used ketamine within 24h of presentation
- require antipsychotics (prescription or PRN by ED staff) or ED administration of other mood-altering medications for the management of acute agitation
- have known renal or liver failure; have neurologic, respiratory, or hemodynamic compromise as determined by the treating ED physician
- have history of stroke or cardiac disease (prior MI, cardiac stents or bypass surgery); or are incarcerated
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 |
|---|---|---|
| KetamineKetamine infusion | Drug | Ketamine |
Primary outcome
Number and Rate of Participants Recruited into the Study throughout study period
Time frame: One year
The study will be considered feasible if the investigators are able to successfully enroll twenty participants into the study over a one year period (~1 - 2 participants per month).
Completion of total infusion of ketamine by participants
Time frame: One year
The study will be considered feasible if the intervention is tolerable to participants with no more than 25% of enrolled participants stopping the infusion of ketamine because of side effects (i.e., early stopping).
Percentage of participants and providers with positive response to ketamine administration
Time frame: One year
The study will be considered feasible if the intervention is considered acceptable to patients and providers (75% positive response on acceptability questionnaires).
1 secondary outcome
Reduction of SI in mood disorders by ketamine
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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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.
Francesca Beaudoin, MD PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine in people with Depressive Disorder, Major and Suicidal Ideation, run by The Miriam Hospital at 1 site in United States.
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 4 inclusion and 5 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 2 Mar 2021. 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 United States. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Principal Investigator (4014444000, Kelly.Wong@Lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Rate of Participants Recruited into the Study throughout study period (time frame: One year). The study lists 3 primary outcomes in all. 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 2 Mar 2021.