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The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.

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ClinicalTrials.gov Identifier: NCT02997722
Recruitment Status : Terminated (Staffing and space deficiencies prevented completion of the study.)
First Posted : December 20, 2016
Results First Posted : April 29, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Allen Richert, University of Mississippi Medical Center

Tracking Information
First Submitted Date  ICMJE December 15, 2016
First Posted Date  ICMJE December 20, 2016
Results First Submitted Date  ICMJE April 16, 2020
Results First Posted Date  ICMJE April 29, 2020
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE March 2, 2017
Actual Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
Inpatient Hospital Length of Stay [ Time Frame: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study. ]
We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
inpatient hospital length of stay [ Time Frame: up to 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.
Official Title  ICMJE Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay
Brief Summary This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.
Detailed Description Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine
    IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
  • Drug: Normal Saline
    IV infusion of 100 ml of normal saline over 45 minutes.
Study Arms  ICMJE
  • Experimental: Ketamine infusion
    Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Normal Saline infusion
    Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
    Intervention: Drug: Normal Saline
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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 12, 2018)
4
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2016)
100
Actual Study Completion Date  ICMJE May 19, 2017
Actual Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women between the ages of 18 and 64
  2. Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations

Exclusion Criteria:

  1. Lifetime history of schizophrenia or other primary psychotic disorder
  2. Current psychotic or manic symptoms
  3. Substance use disorder within one month of admission
  4. Positive urine toxicology at admission
  5. Any lifetime abuse of ketamine or phencyclidine
  6. Systolic BP >180 mmHg or diastolic BP >110 mmHg
  7. Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion
  8. Known central nervous system (CNS) mass
  9. CNS abnormalities
  10. Hydrocephalus
  11. Glaucoma
  12. Acute globe injury
  13. Porphyria
  14. Untreated thyroid disease
  15. Known coronary artery disease with poor functional capacity
  16. Pregnancy
  17. Currently breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (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 NCT02997722
Other Study ID Numbers  ICMJE 2016-0107
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allen Richert, University of Mississippi Medical Center
Study Sponsor  ICMJE Allen Richert
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allen C Richert, MD University of Mississippi Medical Center
PRS Account University of Mississippi Medical Center
Verification Date May 2020

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