Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Primary Purpose
Depression, Major Depressive Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Gynecoligical surgery, Ketamine
Eligibility Criteria
Inclusion Criteria:
- History of or current depression scoring five or above on Goldberg Depression Screen
Exclusion Criteria:
- Uncontrolled hypertension, allergy to ketamine,pregnancy
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Ketamine Group
No ketamine group
Arm Description
This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.
This group will not receive ketamine at induction of general anesthesia.
Outcomes
Primary Outcome Measures
Depression Score Using Goldberg Depression Screening Test
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
just a little
somewhat
moderately
quite a lot
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02422303
First Posted
April 16, 2015
Last Updated
January 22, 2018
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT02422303
Brief Title
Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Official Title
Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder
Keywords
Depression, Gynecoligical surgery, Ketamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine Group
Arm Type
Active Comparator
Arm Description
This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.
Arm Title
No ketamine group
Arm Type
No Intervention
Arm Description
This group will not receive ketamine at induction of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
ketamine
Other Intervention Name(s)
ketalar
Intervention Description
Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
Primary Outcome Measure Information:
Title
Depression Score Using Goldberg Depression Screening Test
Description
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
just a little
somewhat
moderately
quite a lot
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.
Time Frame
One week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of or current depression scoring five or above on Goldberg Depression Screen
Exclusion Criteria:
Uncontrolled hypertension, allergy to ketamine,pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonny C Gillis, M.D.
Organizational Affiliation
Department of Anesthesiology UTHSCSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16894061
Citation
Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
Results Reference
background
PubMed Identifier
24388038
Citation
Naughton M, Clarke G, O'Leary OF, Cryan JF, Dinan TG. A review of ketamine in affective disorders: current evidence of clinical efficacy, limitations of use and pre-clinical evidence on proposed mechanisms of action. J Affect Disord. 2014 Mar;156:24-35. doi: 10.1016/j.jad.2013.11.014. Epub 2013 Dec 10.
Results Reference
background
PubMed Identifier
23689537
Citation
Martinowich K, Jimenez DV, Zarate CA Jr, Manji HK. Rapid antidepressant effects: moving right along. Mol Psychiatry. 2013 Aug;18(8):856-63. doi: 10.1038/mp.2013.55. Epub 2013 May 21.
Results Reference
background
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Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
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