Depression, Major Depressive Disorder
Conditions
Keywords
Depression, Gynecoligical surgery, Ketamine
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.
Interventions
DRUGketamine
Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| No Ketamine Group This group will not receive ketamine at induction of general anesthesia. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Ketamine Group | No Ketamine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
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 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
Population: Participant data were destroyed at study termination, and no analysis was performed, since no longer available.