UnknownEarly Phase 1ketamine

Ketamine for Mood Disorders With Suicidal Ideation

Sponsored by The Miriam Hospital

NCT ID
NCT04099771
Target Enrollment
20 participants
Start Date
2019-07-01
Est. Completion
2021-12-31

About This Study

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.

Conditions Studied

Depressive Disorder, MajorSuicidal Ideation

Interventions

  • Ketamine

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
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

Study Locations (1)

The Miriam Hospital
Providence, Rhode Island, United States

This trial is not recruiting

This study is currently not accepting new participants.

Find recruiting trials
Data Source
ClinicalTrials.gov

Last updated from source

Ketamine for Mood Disorders With Suicidal Ideation | Huxley