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
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Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
Depressive symptoms [ Time Frame: two hours and 24 hours after the ketamine infusion ] change in score in scale Yesavage's abbreviated Geriatric Depression Scale
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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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. |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |