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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 is a Phase 4 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 4 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01856127
The ClinicalTrials.gov registry entry for NCT01856127 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sertraline is the first listed.
NCT01856127 reports 0 study locations.
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.
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