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Completed

NCT Number: NCT03473431

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

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

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Key information

Conditions

Depression in Old Age Ketamine

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Mexico City, 06720, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

single infusion of 0.5 mg / kg ketamine

Control

Other

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

Primary outcomes

  1. Depressive symptoms

    Time frame: two hours and 24 hours after the ketamine infusion

    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 outcomes

  1. Depression rate

    Time frame: two hours and 24 hours after the ketamine infusion

    change in the percentage of patients with criteria for depression based on cutting point of 5 scale

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Collaborators

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2018
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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