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

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ClinicalTrials.gov Identifier: NCT03473431
Recruitment Status : Completed
First Posted : March 22, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Information provided by (Responsible Party):
Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social

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

Condition or disease Intervention/treatment Phase
Depression in Old Age Ketamine Drug: Ketamine Other: control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, dose-controlled follow-up study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: ketamine
single infusion of 0.5 mg / kg ketamine
Drug: Ketamine
single infusion of 0.5 mg / kg ketamine

Sham Comparator: control
physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Other: control
physiological solution at 0.9 % with the same physical characteristics of ketamine solution,




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473431


Locations
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Mexico
Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades
Mexico City, Cdmx, Mexico, 06720
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Investigators
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Principal Investigator: DULCE RASCON MARTINEZ, M.D imss

Publications:
Martinez de la Iglesia, J., Onis Vilches Ma, C., Duenas Herrero, R., Albert Colomer, C., Aguado Taberne, C., & Luque Luque, R. (2002). The Spanish version of the Yesavage abbreviated questionnaire (GDS) to screen depressive dysfunctions in patients older than 65 years. [Spanish]. MEDIFAM - Revista de Medicina Familiar Y Comunitaria, 12(10), 620-630

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Responsible Party: Dulce Maria Rascon Martinez, Principal Investigator, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03473431     History of Changes
Other Study ID Numbers: IMexicanoSS
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketamine
Vision Disorders
Vision, Low
Depression
Behavioral Symptoms
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action