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Trial record 60 of 2663 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Depression
Major Depressive Disorder
Intervention Drug: ketamine
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Group No Ketamine Group
Hide 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
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Ketamine Group No Ketamine Group Total
Hide 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 Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
6
 100.0%
6
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
5
  83.3%
5
  83.3%
10
  83.3%
1.Primary Outcome
Title Depression Score Using Goldberg Depression Screening Test
Hide 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

  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.

Time Frame One week
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Group No Ketamine Group
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Group No Ketamine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Group No Ketamine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Bonnie Gillis
Organization: University of Texas Health Science Center San Antonio
Phone: 210-567-4500
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02422303     History of Changes
Other Study ID Numbers: HSC20150248H
First Submitted: April 16, 2015
First Posted: April 21, 2015
Results First Submitted: December 1, 2017
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018