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NCT02234362 · ClinicalTrials.gov registry record · Phase 4
Vortioxetine for Menopausal Depression
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 47
- Enrollment target
NCT02234362: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT02234362 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 47 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02234362, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 47 participants
- Enrollment target
Study Summary
The broad goal of this study was to examine the efficacy and tolerability of vortioxetine (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women around the menopausal transition. We hypothesized that an eight-week treatment with vortioxetine would promote a significant improvement of depression symptoms and other menopause-related physical symptoms.
Primary Outcome
The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS
Interventions
- DRUG vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-06-12 |
| Est. Completion | 2016-09-29 |
| Phase | Phase 4 |
What the finished NCT02234362 record still lists
NCT02234362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which vortioxetine is the first listed.
NCT02234362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02234362 about?
NCT02234362 is a clinical study titled "Vortioxetine for Menopausal Depression". The broad goal of this study was to examine the efficacy and tolerability of vortioxetine (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women around the menopausal transition. We hypothesized that an eight-week treatment with vortioxetine would promote a signifi...
What is the current status of trial NCT02234362?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 47 participants. The study started on 2015-06-12. Estimated completion is 2016-09-29.
What interventions are being tested in trial NCT02234362?
The interventions under investigation include: vortioxetine (DRUG).
Who is sponsoring clinical trial NCT02234362?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02234362's enrollment target sits among peer trials
47 1348th of 2000 higher than 653 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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