NCT03473431

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

March 15, 2018

Last Update Submit

February 26, 2019

Conditions

Depression in Old AgeKetamine

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    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.

    two hours and 24 hours after the ketamine infusion

Secondary Outcomes (1)

  • Depression rate

    two hours and 24 hours after the ketamine infusion

Study Arms (2)

ketamine

EXPERIMENTAL

single infusion of 0.5 mg / kg ketamine

Drug: Ketamine

control

SHAM COMPARATOR

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

Other: control

Interventions

KetamineDRUG

single infusion of 0.5 mg / kg ketamine

ketamine
controlOTHER

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

control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (10)

  • 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.

    PMID: 28448702BACKGROUND

  • 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.

    PMID: 27591914BACKGROUND

  • 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. doi: 10.1016/s0006-3223(99)00230-9.

    PMID: 10686270BACKGROUND

  • 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. No abstract available.

    PMID: 21734685BACKGROUND

  • Fond G, Loundou A, Rabu C, Macgregor A, Lancon 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.

    PMID: 25038867BACKGROUND

  • George D, Galvez 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.

    PMID: 28739263BACKGROUND

  • 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. doi: 10.2147/NDT.S117146. eCollection 2016.

    PMID: 27843321BACKGROUND

  • 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

    BACKGROUND

  • 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. doi: 10.1192/bjp.188.1.65.

    PMID: 16388072BACKGROUND

  • Volkert J, Schulz H, Harter 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.

    PMID: 23000171BACKGROUND

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • DULCE RASCON MARTINEZ, M.D

    imss

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized, double-blind, dose-controlled follow-up study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

April 15, 2018

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

ME(1)