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NCT01856127 · ClinicalTrials.gov registry record · Phase 4
Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?
A Phase 4 study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT01856127: Clinical Trial Phase 4 study, sponsored by Thomas Jefferson University.
NCT01856127 is a Phase 4 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01856127, a Phase 4 study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a three-center, randomized, double-blind, fixed dose study designed to assess the efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction associated with use of a selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI)compared to switching to sertraline in patients with Major Depressive Disorder (MDD). Vilazodone is a newly introduced, FDA approved antidepressant that is a combined serotonin specific reuptake inhibitor and serotonin 1A receptor partial agonist. In contrast to the SSRIs and SNRIs, appears to have low adverse effects on sexual functioning when compared to placebo.
Interventions
- DRUG Sertraline
- DRUG Vilazodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
Why NCT01856127 stopped before completion
NCT01856127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Sertraline is the first listed.
NCT01856127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01856127 about?
NCT01856127 is a clinical study titled "Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?". This is a three-center, randomized, double-blind, fixed dose study designed to assess the efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction associated with use of a selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI)c...
What is the current status of trial NCT01856127?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2013-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01856127?
The interventions under investigation include: Sertraline (DRUG), Vilazodone (DRUG).
Who is sponsoring clinical trial NCT01856127?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01856127's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 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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