NCT00523705

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 15 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.

Conditions

• PMS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-08-31
• Last updated: 2014-06-06
• Results posted: 2014-06-06

Locations

1 site across 1 country: United States