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NCT02015546 · ClinicalTrials.gov registry record · Phase 3
Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone
A Phase 3 study of Major Depressive Disorder (MDD), sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT02015546 is a Phase 3 study of Major Depressive Disorder (MDD) that has completed, run by Duke University. The registered enrollment target is 70 participants, below the 155-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02015546, a Phase 3 study of Major Depressive Disorder (MDD), has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study is to evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent the recurrence of depression, for the purposes of this study it is considered investigational. The word "investigational" means that the study drug is still being tested in research studies and has not been approved for this use by the FDA.
Conditions Studied
Interventions
- DRUG Vilazodone
Study Locations (1)
North Carolina
- Duke University Medical Center / Civitan Building - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015546
The ClinicalTrials.gov registry entry for NCT02015546 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (55% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder (MDD) appearing as the primary indexed condition, and to 1 intervention - of which Vilazodone is the first listed.
NCT02015546 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02015546 about?
NCT02015546 is a clinical study titled "Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone". This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major ...
What is the current status of trial NCT02015546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2012-12. Estimated completion is 2013-12.
What conditions does trial NCT02015546 study?
This clinical trial studies the following conditions: Major Depressive Disorder (MDD).
What interventions are being tested in trial NCT02015546?
The interventions under investigation include: Vilazodone (DRUG).
Who is sponsoring clinical trial NCT02015546?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02015546 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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