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Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.

A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03473431
Enrollment
90
Registered
2018-03-22
Start date
2018-04-15
Completion date
2018-07-30
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Old Age, Ketamine

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.

Interventions

DRUGKetamine

single infusion of 0.5 mg / kg ketamine

OTHERcontrol

physiological solution at 0.9 % with the same physical characteristics of ketamine solution,

Sponsors

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
CollaboratorOTHER_GOV
Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

randomized, double-blind, dose-controlled follow-up study

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptomstwo hours and 24 hours after the ketamine infusionChange 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

MeasureTime frameDescription
Depression ratetwo hours and 24 hours after the ketamine infusionchange in the percentage of patients with criteria for depression based on cutting point of 5 scale

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026