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

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02422303
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Major Depressive Disorder	Drug: ketamine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketamine Group This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.	Drug: ketamine; Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.; Other Names: ketalar
No Intervention: No ketamine group This group will not receive ketamine at induction of general anesthesia.

Outcome Measures

Primary Outcome Measures

1. Depression Score Using Goldberg Depression Screening Test [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 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Uncontrolled hypertension, allergy to ketamine,pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Bonny C Gillis, M.D., Department of Anesthesiology UTHSCSA

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02422303
• Other Study ID Numbers: HSC20150248H
• First Posted: Apr 21, 2015
• Last Update Posted: Feb 15, 2018
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by The University of Texas Health Science Center at San Antonio: Depression; Gynecoligical surgery; Ketamine
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Ketamine

Study Results

Participant Flow

Arm/Group Title	Ketamine Group	No Ketamine Group
Arm/Group Description	This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.	This group will not receive ketamine at induction of general anesthesia.
Period Title: Overall Study
STARTED	6	6
COMPLETED	5	5
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Ketamine Group	No Ketamine Group	Total
Arm/Group Description	This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.	This group will not receive ketamine at induction of general anesthesia.	Total of all reporting groups
Overall Participants	6	6	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 100%	6 100%	12 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	6 100%	6 100%	12 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	5 83.3%	5 83.3%	10 83.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant data were destroyed at study termination, and no analysis was performed, since no longer available.

Arm/Group Title	Ketamine Group	No Ketamine Group
Arm/Group Description	This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.	This group will not receive ketamine at induction of general anesthesia.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Ketamine Group		No Ketamine Group
Arm/Group Description	This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. ketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.		This group will not receive ketamine at induction of general anesthesia.
All Cause Mortality
	Ketamine Group		No Ketamine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketamine Group		No Ketamine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Ketamine Group		No Ketamine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.