NCT02422303

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 15, 2018

Completed
Last Updated

February 15, 2018

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

April 16, 2015

Results QC Date

December 1, 2017

Last Update Submit

January 22, 2018

Conditions

DepressionMajor Depressive Disorder

Keywords

DepressionGynecoligical surgeryKetamine

Outcome Measures

Primary Outcomes (1)

  • 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.

    One week

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.

Drug: ketamine

No ketamine group

NO INTERVENTION

This group will not receive ketamine at induction of general anesthesia.

Interventions

ketamineDRUG

Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.

Also known as: ketalar
Ketamine Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Uncontrolled hypertension, allergy to ketamine,pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

  • 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.

    PMID: 16894061BACKGROUND

  • 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.

    PMID: 24388038BACKGROUND

  • 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.

    PMID: 23689537BACKGROUND

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Bonnie Gillis
Organization
University of Texas Health Science Center San Antonio
gillis@uthscsa.edu
210-567-4500

Study Officials

  • Bonny C Gillis, M.D.

    Department of Anesthesiology UTHSCSA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 21, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 15, 2018

Results First Posted

February 15, 2018

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)