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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

Tracking Information
First Submitted Date  ICMJE March 15, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE April 15, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Depressive symptoms [ Time Frame: two hours and 24 hours after the ketamine infusion ]
change in score in scale Yesavage's abbreviated Geriatric Depression Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.
Official Title  ICMJE A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Depression in Old Age
  • Ketamine
Intervention  ICMJE
  • Drug: Ketamine
    single infusion of 0.5 mg / kg ketamine
  • Other: control
    physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Study Arms  ICMJE
  • Experimental: ketamine
    single infusion of 0.5 mg / kg ketamine
    Intervention: Drug: Ketamine
  • Sham Comparator: control
    physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
    Intervention: Other: control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03473431
Other Study ID Numbers  ICMJE IMexicanoSS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social
Study Sponsor  ICMJE Instituto Mexicano del Seguro Social
Collaborators  ICMJE Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Investigators  ICMJE
Principal Investigator: DULCE RASCON MARTINEZ, M.D imss
PRS Account Instituto Mexicano del Seguro Social
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP