Clinical TrialDepressive DisordersKetaminePlaceboCompleted

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

Randomised, double-blind, parallel trial (n=90) testing a single 0.5 mg/kg IV ketamine infusion over 2 hours versus saline in patients aged ≥60 undergoing ophthalmologic surgery to assess depressive symptoms.

Target Enrollment
90 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

Depression in older adults is common and associated with worse medical comorbidity and quality of life. This study evaluated the effect of a single ketamine infusion (0.5 mg/kg) on depressive symptoms in patients aged 60+ undergoing ophthalmologic surgery.

Randomised, double-blind, parallel design (n=90) comparing ketamine 0.5 mg/kg IV given as a slow 2-hour infusion to 0.9% saline. Depressive symptoms were measured with the abbreviated Geriatric Depression Scale (Yesavage) at baseline, recovery end, and 24 hours post-surgery.

Study Protocol

Preparation

sessions

Dosing

1 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV infusion 0.5 mg/kg over 2 hours

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Slow infusion over 2 hours

Control (saline)

inactive

0.9% saline matched to ketamine solution (sham comparator)

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% saline, matched physical characteristics

Participants

Ages
60 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* 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\n* Intraocular pressure <20 mm Hg\n* ASA functional capacity from I to III

Exclusion Criteria

  • Exclusion Criteria:\n\n* Previous antidepressants medications\n* Cognitive impairment was found according to the Short Portable Mental Status Questionnaire (SPMSQ) assessment\n* History of psychosis, schizophrenia, or nephropathy\n* History of difficulties controlling arterial blood pressure, uncontrolled hepatic disorders, or prior adverse response to ketamine according to clinical records

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment90 participants
  • Timeline
    Start: 2018-04-15
    End: 2018-07-30
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Centro Medico Nacional Siglo XXI. UMAE Hospital de Especialidades — Mexico City, Mexico City, Mexico

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