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Trial record 60 of 2701 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT02422303
Recruitment Status : Terminated
First Posted : April 21, 2015
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE April 16, 2015
First Posted Date  ICMJE April 21, 2015
Results First Submitted Date  ICMJE December 1, 2017
Results First Posted Date  ICMJE February 15, 2018
Last Update Posted Date February 15, 2018
Study Start Date  ICMJE December 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
Depression Score Using Goldberg Depression Screening Test [ Time Frame: One week ]
The Goldberg screening test consists of 18 questions which are answered based upon the previous 10-14 days to assess depression: 0-not at all
  1. just a little
  2. somewhat
  3. moderately
  4. quite a lot
  5. very much
The scores are summed, and the ranges are assessed: 0 - 9 No depression likely 10 - 21 Possible symptoms that may be due to depression or other medical issues. 22 - 35 Mild to Moderate Depression. 36 - 53 Moderate to Severe Depression 54 and up Severely Depressed The higher the score, the more severe you depression is likely to be.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
Lower depression score on Goldberg Depression Screening (less depression) [ Time Frame: One week ]
Change History Complete list of historical versions of study NCT02422303 on ClinicalTrials.gov Archive Site
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 Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Official Title  ICMJE Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Brief Summary Ketamine has been shown to have an antidepressant effect when given intravenously in doses of 2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known in this instance to decrease postoperative pain. No one has studied whether or not ketamine when given in doses used during general anesthesia (0.5mg/kg intravenous) has an antidepressant effect on surgical patients who suffer from depression. The study is designed to determine whether or not a small dose of ketamine when given at the induction of anesthesia could have an antidepressant effect on surgical patients with depression.
Detailed Description

Non-pregnant females between the ages of 18-65 who are being admitted for gynecological surgery will be given a bedside Goldberg depression screen as part of their routine preanesthetic assessment. If the patient scores five or above on the Goldberg depression screening, they will be asked if they would like to enroll in the study. Exclusion criteria include uncontrolled hypertension, pregnancy, or allergy to ketamine.

Once the patient is consented they will be randomized to one of two groups. Every patient will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their induction for general anesthesia. Group B will not receive ketamine as part of their anesthetic. All other induction drugs will be at the discretion of the anesthesiologist performing the anesthetic.

The patients will be seen by a separate anesthesia provider (who is blinded to the group the patient is in) and the results of the depression screening will be added to the patient's data sheet.

The patients will be followed again one week after their surgery either in their hospital room (if still hospitalized) or by phone. They will again be given the Goldberg Depression screen and the data will again be added to their data sheet.

Several times during the study and at its conclusion the data will be matched with the patients group in order to assess for adverse events such as suicidal ideations, nausea and vomiting. If adverse events are noted, the study design will be altered to take into account the adverse events.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Major Depressive Disorder
Intervention  ICMJE Drug: ketamine
Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
Other Name: ketalar
Study Arms  ICMJE
  • Active Comparator: Ketamine Group
    This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.
    Intervention: Drug: ketamine
  • No Intervention: No ketamine group
    This group will not receive ketamine at induction of general anesthesia.
Publications *

*   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 20, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2015)
200
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of or current depression scoring five or above on Goldberg Depression Screen

Exclusion Criteria:

  • Uncontrolled hypertension, allergy to ketamine,pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 NCT02422303
Other Study ID Numbers  ICMJE HSC20150248H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bonny C Gillis, M.D. Department of Anesthesiology UTHSCSA
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2016

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