Ketamine for Mood Disorders With Suicidal Ideation

Status unconfirmed · Early Phase 1

Conditions studied: Depressive Disorder, Major, Suicidal Ideation

In brief

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.

Key facts

Study ID

NCT04099771

Run by

The Miriam Hospital

People needed

20

Starts

2019-07-01

Expected to finish

2021-12-31

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• The Miriam Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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