CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 252 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00536198
NCT00536198Phase 4Completed
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Symptom Onset Antidepressant Treatment for PMDD

Yale University·interventional·Posted Sep 27, 2007·Updated Apr 14, 2017

In Brief

A Phase 4 clinical trial evaluating Sertraline and Placebo for Premenstrual Dysphoric Disorder. Completed, enrolled 252 participants across 3 sites.

Detailed Summary

This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremenstrual Dysphoric Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2007
Enrollment StartNov 6, 2007
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.8 years ago

Interventions

Sertralinedrug

50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.

Placebodrug

50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.