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NCT01973283 · ClinicalTrials.gov registry record · Phase 4
Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT01973283: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT01973283 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01973283, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study 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).
Primary Outcome
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Interventions
- DRUG Antidepressant Medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-02-19 |
| Est. Completion | 2020-12-05 |
| Phase | Phase 4 |
What the finished NCT01973283 record still lists
NCT01973283 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Antidepressant Medication is the first listed.
NCT01973283 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01973283 about?
NCT01973283 is a clinical study titled "Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults". 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 Epidem...
What is the current status of trial NCT01973283?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2014-02-19. Estimated completion is 2020-12-05.
What interventions are being tested in trial NCT01973283?
The interventions under investigation include: Antidepressant Medication (DRUG).
Who is sponsoring clinical trial NCT01973283?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01973283's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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