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NCT01117857 · ClinicalTrials.gov registry record · Phase 4
Duloxetine for Menopausal Depression
A Phase 4 study of Depression and Menopause, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01117857: Completed Phase 4 study of Depression and Menopause, sponsored by Massachusetts General Hospital.
NCT01117857 is a Phase 4 study of Depression and Menopause that has completed, run by Massachusetts General Hospital. The registered enrollment target is 29 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01117857, a Phase 4 study of Depression and Menopause, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to determine if an eight-week intervention with duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in depression symptoms in menopausal women. The secondary aim of the study is to examine if an eight-week intervention with duloxetine significantly reduces vasomotor symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in vasomotor symptoms in menopausal women.
Primary Outcome
The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.
Conditions Studied
Interventions
- DRUG Duloxetine
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
What the finished NCT01117857 record still lists
NCT01117857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Duloxetine is the first listed.
NCT01117857 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01117857 about?
NCT01117857 is a clinical study titled "Duloxetine for Menopausal Depression". The primary objective of the study is to determine if an eight-week intervention with duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in depression symptoms in menopausa...
What is the current status of trial NCT01117857?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2009-08. Estimated completion is 2011-06.
What conditions does trial NCT01117857 study?
This clinical trial studies the following conditions: Depression, Menopause, Vasomotor Symptoms.
What interventions are being tested in trial NCT01117857?
The interventions under investigation include: Duloxetine (DRUG).
Who is sponsoring clinical trial NCT01117857?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01117857 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01117857's enrollment target sits among peer trials
29 576th of 679 higher than 99 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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