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NCT02777372 · ClinicalTrials.gov registry record · Phase 4
Stress & Premenstrual Symptoms Study
A Phase 4 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
NCT02777372: Completed Phase 4 study, sponsored by Johns Hopkins University.
NCT02777372 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 84 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02777372, a Phase 4 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
Study Summary
This study that aims to evaluate the psychophysiology of premenstrual mood disorders (PMDs) at baseline and after treatment with sertraline. Participants will include women with PMDs and healthy female controls. Participation involves a baseline visit to determine eligibility and three study visits that include questionnaires and stress reactivity assessment via an acoustic startle paradigm. Female participants with PMDs will receive sertraline during the premenstrual phase.
Primary Outcome
Acoustic startle response (ASR) is measured during the follicular and luteal phase of the menstrual cycle in controls and those with PMDD. Magnitude of ASR is measured using the eyeblink reflex, by recording activity from the orbicularis oculi muscle. Recording is performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. For the primary outcome of baseline ASR magnitude over the menstrual cycle, peak a
Interventions
- DRUG Sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2021-12-01 |
| Phase | Phase 4 |
What the finished NCT02777372 record still lists
NCT02777372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Sertraline is the first listed.
NCT02777372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02777372 about?
NCT02777372 is a clinical study titled "Stress & Premenstrual Symptoms Study". This study that aims to evaluate the psychophysiology of premenstrual mood disorders (PMDs) at baseline and after treatment with sertraline. Participants will include women with PMDs and healthy female controls. Participation involves a baseline visit to determine eligibility and three study visits ...
What is the current status of trial NCT02777372?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2016-04-01. Estimated completion is 2021-12-01.
What interventions are being tested in trial NCT02777372?
The interventions under investigation include: Sertraline (DRUG).
Who is sponsoring clinical trial NCT02777372?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02777372's enrollment target sits among peer trials
84 929th of 2000 higher than 1,064 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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