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Depression in Old AgeNCT03473431

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

A study testing Ketamine in people with Depression in Old Age and Ketamine, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Depression in Old Age, Ketamine
What is being tested?
Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteMexico
Study dates
15 Apr 2018to 30 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades

    Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

Official title: A Pilot Study of a Single Infusion of Ketamine in Relief of Depressive Symptoms of Elderly Patients With Visual Impairment.

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

Read the 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.

Being tested
Ketamine, control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    single infusion of 0.5 mg / kg ketamine

  • controlOther

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

Study groups in NCT03473431
Study groupRoleWhat they receive
ketamineExperimentalsingle infusion of 0.5 mg / kg ketamine
Receives: Drug: Ketamine
controlSham comparatorphysiological solution at 0.9 % with the same physical characteristics of ketamine solution,
Receives: Other: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: two hours and 24 hours after the ketamine infusion

Secondary outcomes (1)

  1. Depression rate

    change in the percentage of patients with criteria for depression based on cutting point of 5 scale

    Measured: two hours and 24 hours after the ketamine infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study start15 Apr 2018
  3. Primary completion30 Jun 2018
  4. Study completion30 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, dose-controlled follow-up study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473431
Sponsor's protocol ID
IMexicanoSS
Status last verified
Feb 2019
First submitted
15 Mar 2018
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 28448702

  • 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.

    PubMed 27591914

  • 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.

    PubMed 10686270

  • 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.

    PubMed 21734685

  • 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.

    PubMed 25038867

  • 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.

    PubMed 28739263

  • 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.

    PubMed 27843321

  • 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. doi: 10.1192/bjp.188.1.65.

    PubMed 16388072

  • 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.

    PubMed 23000171

Questions about this trial

What is this clinical trial studying?

A study testing Ketamine in people with Depression in Old Age and Ketamine, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive symptoms (time frame: two hours and 24 hours after the ketamine infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473431, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.

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