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Unknown statusEarly Phase 1

Ketamine for Mood Disorders With Suicidal Ideation

NCT04099771 · The Miriam Hospital

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

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. 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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number and Rate of Participants Recruited into the Study throughout study period

    Measured over One year

  • Completion of total infusion of ketamine by participants

    Measured over One year

  • Percentage of participants and providers with positive response to ketamine administration

    Measured over One year

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Where

1 study site

FacilityCityRegionCountry
The Miriam HospitalProvidenceRhode IslandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04099771 on ClinicalTrials.gov →

Last updated in the registry 2021-03-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits