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

Completed · Phase 4

Conditions studied: Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder, NOS

In brief

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).

Key facts

Study ID

NCT01973283

Run by

New York State Psychiatric Institute

People needed

100

Starts

2014-02-19

Expected to finish

2020-12-05

Last updated by the study team

2021-01-29

Who can join

Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Anyone with 1 or more characteristics of frailty
• HRSD>16 and a DSM-IV depressive disorder (e.g. MDD, Dysthymia)
• Capable of providing informed consent
• Currently followed by a PCP (had an eval in last 6-months)

You may not qualify if…

• Acute cancer treatment
• Acute, severe or unstable medical illness
• End stage medical illness (e.g. liver, kidney, pulmonary)
• Mini Mental Exam < 24 or a diagnosis of dementia
• Individuals who do not have capacity to consent
• Diagnosis of substance abuse or dependence (last 12 months), excluding Nicotine dependence
• History of psychosis or psychotic disorder or bipolar disorder
• Patient is considered a significant risk of suicide
• Subject is considered based on history to be unlikely to respond to the single agent antidepressant (i.e., subjects with treatment resistant depression, including subjects with previous treatment with ECT)
• History of allergic or adverse reaction to escitalopram or duloxetine, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) or duloxetine (at least 4 weeks at dose of 90mg).

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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