Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD), Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 60 - 95 |
| Updated: | 10/13/2018 |
| Start Date: | September 2011 |
| End Date: | July 2019 |
| Contact: | Kiley Cappetta |
| Email: | kiley.cappetta@nyspi.columbia.edu |
| Phone: | 646-774-8652 |
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).
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).
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 it is focuses on a group of older adults who have
been unrepresented (via exclusion criteria) in previous clinical studies (frail older adults
with comorbid depressive symptoms), and it treats the comorbid depressive symptoms and
targets characteristics of the frailty syndrome in the hopes of altering the prognostic
trajectory of this clinical sample. This protocol serves two purposes: 1. It tests the
feasibility of recruiting and retaining frail older adults with depressive symptoms in a
treatment trial, and 2. It provides pilot data for the effectiveness of an antidepressant
medication on treating the characteristics of frailty and the comorbid depressive symptoms.
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 it is focuses on a group of older adults who have
been unrepresented (via exclusion criteria) in previous clinical studies (frail older adults
with comorbid depressive symptoms), and it treats the comorbid depressive symptoms and
targets characteristics of the frailty syndrome in the hopes of altering the prognostic
trajectory of this clinical sample. This protocol serves two purposes: 1. It tests the
feasibility of recruiting and retaining frail older adults with depressive symptoms in a
treatment trial, and 2. It provides pilot data for the effectiveness of an antidepressant
medication on treating the characteristics of frailty and the comorbid depressive symptoms.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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).
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Patrick Brown, PhD
Phone: 646-774-8652
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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