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NCT00048854 · ClinicalTrials.gov registry record · Phase 1

Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

A Phase 1 study of Premenstrual Syndrome, sponsored by Yale University.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target
1
Study location

NCT00048854: Completed Phase 1 study of Premenstrual Syndrome, sponsored by Yale University.

NCT00048854 is a Phase 1 study of Premenstrual Syndrome that has completed, run by Yale University. The registered enrollment target is 66 participants, below the 124-participant average among 6 other Premenstrual Syndrome trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00048854, a Phase 1 study of Premenstrual Syndrome, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target
1
Study location

Study Summary

This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms.

Conditions Studied

Interventions

  • DRUG Sertraline
  • OTHER Treatment as usual (TAU)

Study Locations (1)

Connecticut

  • Yale School of Medicine - New Haven

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2001-09
Est. Completion 2008-01
Phase Phase 1
Yale University

1,492 total trials

What the finished NCT00048854 record still lists

NCT00048854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 124-participant average among 6 other Premenstrual Syndrome trials with a reported enrollment target (47% lower).

The record links to 1 condition, with Premenstrual Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Sertraline is the first listed.

NCT00048854 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT00048854 about?

NCT00048854 is a clinical study titled "Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder". This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms.

What is the current status of trial NCT00048854?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2001-09. Estimated completion is 2008-01.

What conditions does trial NCT00048854 study?

This clinical trial studies the following conditions: Premenstrual Syndrome.

What interventions are being tested in trial NCT00048854?

The interventions under investigation include: Sertraline (DRUG), Treatment as usual (TAU) (OTHER).

Who is sponsoring clinical trial NCT00048854?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00048854 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00048854, the US trial registry maintained by the National Library of Medicine. NCT00048854 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.