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

• ClinicalTrials.gov Identifier: NCT03473431
• Recruitment Status: Completed
• First Posted: March 22, 2018
• Last Update Posted: February 28, 2019
• Sponsor: Instituto Mexicano del Seguro Social
• 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: March 15, 2018
• First Posted Date: March 22, 2018
• Last Update Posted Date: February 28, 2019
• Actual Study Start Date: April 15, 2018
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Depression in Old Age
• Ketamine

Intervention

• 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

• 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 *

• Andrade C. Ketamine for Depression, 1: Clinical Summary of Issues Related to Efficacy, Adverse Effects, and Mechanism of Action. J Clin Psychiatry. 2017 Apr;78(4):e415-e419. doi: 10.4088/JCP.17f11567. Review.
• Arandjelovic K, Eyre HA, Lavretsky H. Clinicians' Views on Treatment-Resistant Depression: 2016 Survey Reports. Am J Geriatr Psychiatry. 2016 Oct;24(10):913-7. doi: 10.1016/j.jagp.2016.05.010. Epub 2016 May 18.
• Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4.
• Collins PY, Patel V, Joestl SS, March D, Insel TR, Daar AS; Scientific Advisory Board and the Executive Committee of the Grand Challenges on Global Mental Health, Anderson W, Dhansay MA, Phillips A, Shurin S, Walport M, Ewart W, Savill SJ, Bordin IA, Costello EJ, Durkin M, Fairburn C, Glass RI, Hall W, Huang Y, Hyman SE, Jamison K, Kaaya S, Kapur S, Kleinman A, Ogunniyi A, Otero-Ojeda A, Poo MM, Ravindranath V, Sahakian BJ, Saxena S, Singer PA, Stein DJ. Grand challenges in global mental health. Nature. 2011 Jul 6;475(7354):27-30. doi: 10.1038/475027a.
• Fond G, Loundou A, Rabu C, Macgregor A, Lançon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20. Review.
• George D, Gálvez V, Martin D, Kumar D, Leyden J, Hadzi-Pavlovic D, Harper S, Brodaty H, Glue P, Taylor R, Mitchell PB, Loo CK. Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression. Am J Geriatr Psychiatry. 2017 Nov;25(11):1199-1209. doi: 10.1016/j.jagp.2017.06.007. Epub 2017 Jun 13.
• Han Y, Chen J, Zou D, Zheng P, Li Q, Wang H, Li P, Zhou X, Zhang Y, Liu Y, Xie P. Efficacy of ketamine in the rapid treatment of major depressive disorder: a meta-analysis of randomized, double-blind, placebo-controlled studies. Neuropsychiatr Dis Treat. 2016 Nov 3;12:2859-2867. eCollection 2016.
• 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
• Stek ML, Vinkers DJ, Gussekloo J, van der Mast RC, Beekman AT, Westendorp RG. Natural history of depression in the oldest old: population-based prospective study. Br J Psychiatry. 2006 Jan;188:65-9.
• Volkert J, Schulz H, Härter M, Wlodarczyk O, Andreas S. The prevalence of mental disorders in older people in Western countries - a meta-analysis. Ageing Res Rev. 2013 Jan;12(1):339-53. doi: 10.1016/j.arr.2012.09.004. Epub 2012 Sep 19. Review.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 15, 2018): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 30, 2018
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT03473431
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social
• Study Sponsor: Instituto Mexicano del Seguro Social
• Collaborators: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Investigators

• Principal Investigator: DULCE RASCON MARTINEZ, M.D; imss

• PRS Account: Instituto Mexicano del Seguro Social
• Verification Date: February 2019