CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Antidepressant Medicationdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01973283
NCT01973283Phase 4Completed

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

New York State Psychiatric Institute·interventional·Posted Oct 31, 2013·Updated Jan 29, 2021

In Brief

A Phase 4 clinical trial evaluating Antidepressant Medication for Major Depressive Disorder and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 31, 2013
Enrollment StartFeb 19, 2014
Primary CompletionDec 5, 2019
Study CompletionDec 5, 2020
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 12.7 years ago

Interventions

Antidepressant Medicationdrug

If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.