Trial Outcomes & Findings for Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms (NCT NCT02422303)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

One week

Results posted on

2018-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Group 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.	No Ketamine Group This group will not receive ketamine at induction of general anesthesia.
Overall Study STARTED	6	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine Group 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.	No Ketamine Group This group will not receive ketamine at induction of general anesthesia.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine Group n=6 Participants 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.	No Ketamine Group n=6 Participants This group will not receive ketamine at induction of general anesthesia.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: One week

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Ketamine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Ketamine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bonnie Gillis

University of Texas Health Science Center San Antonio

Phone: 210-567-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place