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Ketamine for Mood Disorders With Suicidal Ideation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099771
Recruitment Status : Unknown
Verified September 2020 by The Miriam Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2019
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
Reduction of SI in mood disorders by ketamine [ Time Frame: 30 days ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 19, 2019)
  • Effect on in-patient length of stay [ Time Frame: 30 days ]
    In exploratory analyses, the investigators will also examine a number of other outcomes including: the average length of stay of inpatient admission
  • Effect on indication of other medication administration [ Time Frame: 30 days ]
    In exploratory analyses, the investigators will also examine concomitant medications received (e.g., for depression, agitation) by analyzing the percentage of patients who receive other medications in the emergency department.
  • Number of participants with return visit to the Emergency Department [ Time Frame: 30 days ]
    In exploratory analyses, the investigators will also examine 30-day return ED visits via patient self-report and review of medical records.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ketamine for Mood Disorders With Suicidal Ideation
Official Title  ICMJE Low Dose Ketamine for Acute Management of Mood Disorders With Suicidal Ideation
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder, Major
  • Suicidal Ideation
Intervention  ICMJE Drug: Ketamine
Ketamine infusion
Study Arms  ICMJE Experimental: Ketamine
A total of 20 patients identified as having suicidal ideation will receive ketamine at 0.5mg/kg infused intravenously over 40 minutes.
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04099771
Other Study ID Numbers  ICMJE 1348833
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The Miriam Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Miriam Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesca Beaudoin, MD PhD Rhode Island Hospital
PRS Account The Miriam Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP