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NCT04697693 · ClinicalTrials.gov registry record · Phase 4
Antidepressant Response in Older Adults With Comorbid PTSD and MDD
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT04697693: Clinical Trial Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT04697693 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04697693, a Phase 4 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
In the Investigator's ongoing studies of Posttraumatic Stress Disorder (PTSD) in older adults, it has been found that older adults with PTSD frequently meet the criteria for comorbid Major Depressive Disorder (MDD). Moreover, relative to trauma-exposed healthy controls (TEHCs), elders with PTSD manifest executive function deficits, fatigability, and mobility and physical function deficits that are consistent with what the investigator has observed in depressed older adults. Yet, the investigator has found that very few older adults with combined PTSD/MDD have received appropriate antidepressant treatment for their condition. These findings give rise to the questions of (1) how effective is antidepressant treatment for depressive symptoms in the context of PTSD/MDD and (2) are cognitive and physical function deficits in PTSD/MDD patients reversible with effective antidepressant treatment?
Primary Outcome
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. The change in Hamilton Rating Score for Depression (HRSD) from baseline to week 8 wa
Interventions
- DRUG Duloxetine
- DRUG Escitalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-03-03 |
| Est. Completion | 2021-05-20 |
| Phase | Phase 4 |
Why NCT04697693 stopped before completion
NCT04697693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Duloxetine is the first listed.
NCT04697693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04697693 about?
NCT04697693 is a clinical study titled "Antidepressant Response in Older Adults With Comorbid PTSD and MDD". In the Investigator's ongoing studies of Posttraumatic Stress Disorder (PTSD) in older adults, it has been found that older adults with PTSD frequently meet the criteria for comorbid Major Depressive Disorder (MDD). Moreover, relative to trauma-exposed healthy controls (TEHCs), elders with PTSD mani...
What is the current status of trial NCT04697693?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2021-03-03. Estimated completion is 2021-05-20.
What interventions are being tested in trial NCT04697693?
The interventions under investigation include: Duloxetine (DRUG), Escitalopram (DRUG).
Who is sponsoring clinical trial NCT04697693?
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 NCT04697693's enrollment target sits among peer trials
1 2000th of 2000 the lowest 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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