Ketamine for Mood Disorders With Suicidal Ideation

NCT04099771 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: 1348833
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder, Major; Suicidal Ideation

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  One year

Secondary Outcomes (1)

• Reduction of SI in mood disorders by ketamine

  30 days

Other Outcomes (3)

• Effect on in-patient length of stay

  30 days

• Effect on indication of other medication administration

  30 days

• Number of participants with return visit to the Emergency Department

  30 days

Study Arms (1)

Ketamine

EXPERIMENTAL

A total of 20 patients identified as having suicidal ideation will receive ketamine at 0.5mg/kg infused intravenously over 40 minutes.

Drug: Ketamine

Interventions

Ketamine DRUG

Ketamine infusion

Ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Francesca Beaudoin, MD PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

4014444000; Kelly.Wong@Lifespan.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: September 23, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 2, 2021

Record last verified: 2020-09

Locations

US (1)