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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099771
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital

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.


Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Suicidal Ideation Drug: Ketamine Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Ketamine for Acute Management of Mood Disorders With Suicidal Ideation
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
A total of 20 patients identified as having suicidal ideation will receive ketamine at 0.5mg/kg infused intravenously over 40 minutes.
Drug: Ketamine
Ketamine infusion




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099771


Contacts
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Contact: Principal Investigator 4014444000 Kelly.Wong@Lifespan.org

Locations
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United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Principal Investigator         
Principal Investigator: Francesca Beaudoin, MD PhD         
Sponsors and Collaborators
The Miriam Hospital
Investigators
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Principal Investigator: Francesca Beaudoin, MD PhD Rhode Island Hospital
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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT04099771    
Other Study ID Numbers: 1348833
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Depressive Disorder
Mood Disorders
Suicidal Ideation
Depressive Disorder, Major
Mental Disorders
Behavioral Symptoms
Suicide
Self-Injurious Behavior
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action