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Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

NCT00523705 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-06-06

Study results available
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Summary

The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.

Conditions

  • PMS

Interventions

DRUG

escitalopram

10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.

OTHER

placebo

Placebo tablets matched to drug

Sponsors & Collaborators

Principal Investigators

  • Ellen Freeman · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00523705 on ClinicalTrials.gov