Clinical Trial: Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults

Brief Summary: The goal of this open-administration treatment study of citalopram (or duloxetine) is to evaluate the effect of antidepressant medication on treating the syndrome of "frailty" in older adults with depressive symptoms. Patients with significant depressive symptoms (defined as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8 weeks to test whether antidepressant medication improves both the syndrome of frailty and depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and eligible to participate in the study will be treated with an antidepressant medication and assessed on the primary outcome variables (characteristics of frailty, depressive symptoms) as well as on secondary variables which include cognition (global cognition, episodic memory, executive function), and function (physical mobility, instrumental activities of daily living, and social functioning) prior to treatment initiation and following 8-weeks of treatment. The hypotheses for this protocol predict that we will discover a significant improvement on both frailty characteristics and depressive symptoms in this clinical population when treated with antidepressant medication (citalopram or duloxetine).

Detailed Summary:

Frailty, "a syndrome of decreased resiliency and reserves", is defined by five characteristics: 1)"shrinking" (definition: unintentional weight loss of > 10 lbs in prior year, or > 5% loss of body weight in prior year at follow-up), 2) weakness (definition: grip strength in lowest 20% at baseline, adjusted for gender and BMI), 3) poor endurance/energy (definition: self-report of exhaustion on 2 items on the CES-D), 4) slowness (definition: slowest 20% on timed 4 meter or 15 foot walk, adjusted for gender and standing height), and 5) low physical activity (definition: weighted score of kilocalories expended per week as calculated from the Minnesota Leisure Time Activity questionnaire). Frailty is associated with poor prognosis including hospitalization, falls, worsening disability and mobility, and death.

Data from the Cardiovascular Health Study document the rate of comorbid depressive symptoms in frail older adults (16.2% of older adults with at least 1 frailty characteristic had a CES-D > 10, including 31% of older adults with 3 or more frailty characteristics, compared to 2.6% of nonfrail older adults) despite study exclusion of individuals who were taking an antidepressant (this is in part why we chose to include patients with a CES-D of > 10, rather than requiring a diagnosis of a depressive disorder such as major depression or dysthymia for this study). The relationship between frailty and depression however goes beyond this association; the five defining characteristics of frailty (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) overlap significantly with symptoms of geriatric depression (decreased energy and motivation, psychomotor slowing, weight loss, decreased participation in leisure activities).

The proposed study is innovative in that
Sponsor: New York State Psychiatric Institute

Current Primary Outcome: Hamilton Rating Scale for Depression [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Beck Depression Inventory [ Time Frame: 1 Day ]
  • World Health Organization Disability Assessment Scale 2 [ Time Frame: 8 weeks ]
    Assesses level of functioning of patient, a component of the frailty evaluation. Conducted at baseline and week 8.
  • Measure of Everyday Cognition [ Time Frame: 8 Weeks ]
    An assessment of the participant's cognitive functioning, part of the frailty assessment. Conducted at baseline and week 8.
  • Short Physical Performance Battery [ Time Frame: 8 weeks ]
    An assessment of the participant's physical abilities and strength, part of the frailty assessment. Conducted at baseline and week 8.
  • Selective Reminding Task [ Time Frame: 8 weeks ]
    An assessment of the participant's memory. Conducted at baseline and week 8.
  • Stroop Color-Word test [ Time Frame: 8 Weeks ]
    An assessment of the participant's executive functioning. Conducted at baseline and week 8.
  • Trailmaking Test A & B [ Time Frame: 8 weeks ]
    An assessment of the participant's executive functioning. Conducted at baseline and week 8.


Original Secondary Outcome: Same as current

Information By: New York State Psychiatric Institute

Dates:
Date Received: October 25, 2013
Date Started: September 2011
Date Completion: July 2018
Last Updated: December 27, 2016
Last Verified: December 2016