Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.
Primary Purpose
Depression in Old Age, Ketamine
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Ketamine
control
Sponsored by
About this trial
This is an interventional other trial for Depression in Old Age
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 60 years or older who due to the severity of visual disability required to be operated on for eye surgery using retrobulbar block
- Intraocular pressure <20 mm Hg and
- ASA functional capacity from I to III
Exclusion Criteria:
- Previous antidepressants medications
- Cognitive impairment was found according to the Short Portable Mental Status Questionnaire (SPMSQ) assessment
- In case of a history of psychosis, schizophrenia, nephropathy
- They had a history of difficulties to control arterial blood pressure, uncontrolled hepatic disorders or had a history of adverse response to ketamine according clinical records
Sites / Locations
- Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
ketamine
control
Arm Description
single infusion of 0.5 mg / kg ketamine
physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Outcomes
Primary Outcome Measures
Depressive symptoms
Change in the total score in a scale for Geriatric Depression the "Geriatric Depression Scale. " It will be consider as an outcome the total score. The scale have a maximun score of 15 and minimum of 0. Higher values are considered a worse outcome.
Secondary Outcome Measures
Depression rate
change in the percentage of patients with criteria for depression based on cutting point of 5 scale
Full Information
NCT ID
NCT03473431
First Posted
March 15, 2018
Last Updated
February 26, 2019
Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
1. Study Identification
Unique Protocol Identification Number
NCT03473431
Brief Title
Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.
Official Title
A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
the prevalence of depression in elderly is from 4 to 30% and is associated with a lower quality of life mayor medical comorbidity, and increased mortality. Although there are various treatments for depression in the elderly, the study of interventions in resistant depression is limited and there are few reports of the efficacy and safety profile of alternative interventions such as ketamine in the elderly. The final objective of the present study is to report the effects of a single infusion of ketamine on the depressive symptoms in patients undergoing ophthalmologic surgery
Detailed Description
The final objective of the present study is to report the effects of a single infusion of 0.5 mg / kg ketamine in infusion on depressive symptoms assessed using the scale Yesavage's abbreviated Geriatric Depression Scale.
This is a randomized double-blind follow-up study in patients over 60 years of age with ocular pathology who required ophthalmological surgery with retrobulbar block and conscious sedation with ketamine. The sample consisted of two groups: a control group and an experimental group with ketamine. The dose used for the study was 0.5mg / kg in slow infusion for two hours. In both groups the Yesavage's questionnaire was applied at three different times; Basally, at the end of the recovery and at 24 hours after the surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age, Ketamine
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, dose-controlled follow-up study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketamine
Arm Type
Experimental
Arm Description
single infusion of 0.5 mg / kg ketamine
Arm Title
control
Arm Type
Sham Comparator
Arm Description
physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
single infusion of 0.5 mg / kg ketamine
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
Change in the total score in a scale for Geriatric Depression the "Geriatric Depression Scale. " It will be consider as an outcome the total score. The scale have a maximun score of 15 and minimum of 0. Higher values are considered a worse outcome.
Time Frame
two hours and 24 hours after the ketamine infusion
Secondary Outcome Measure Information:
Title
Depression rate
Description
change in the percentage of patients with criteria for depression based on cutting point of 5 scale
Time Frame
two hours and 24 hours after the ketamine infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women aged 60 years or older who due to the severity of visual disability required to be operated on for eye surgery using retrobulbar block
Intraocular pressure <20 mm Hg and
ASA functional capacity from I to III
Exclusion Criteria:
Previous antidepressants medications
Cognitive impairment was found according to the Short Portable Mental Status Questionnaire (SPMSQ) assessment
In case of a history of psychosis, schizophrenia, nephropathy
They had a history of difficulties to control arterial blood pressure, uncontrolled hepatic disorders or had a history of adverse response to ketamine according clinical records
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DULCE RASCON MARTINEZ, M.D
Organizational Affiliation
imss
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
City
Mexico City
State/Province
Cdmx
ZIP/Postal Code
06720
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
28448702
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
10686270
Citation
Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
Results Reference
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PubMed Identifier
21734685
Citation
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Citation
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Citation
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Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.
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