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

May 29, 2014 updated by: University of Pennsylvania
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Dept OB/GYN, Mudd Professorship Suite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females 15-19 years of age
  • Regular menstrual cycles of 22-35 days
  • In general good health
  • Medically approved birth control method if sexually active
  • Evidence of ovulation
  • Meeting all symptom criteria for PMS
  • Signed informed consent
  • Subjects under age 18 must also have signed parental consent

Exclusion Criteria:

  • Current use of any treatment for PMS.
  • Psychotropic or other medications that may compromise the study drug.
  • Pregnancy, intending pregnancy or breast feeding.
  • Not using a medically approved birth control method if sexually active.
  • Significant medical or gynecological abnormalities.
  • Irregular menses, any gynecologic disorder.
  • Any severe or unstable medical illness.
  • Any current major psychiatric diagnosis or any history of a major psychiatric diagnosis.
  • Any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar disorder, psychosis or severe personality disorder.
  • Use of triptans (Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, Relpax).
  • Use of medicines that include dextromethorphan such as Tylenol or Vicks cough medicines.
  • Use of the pain medication meperidine.
  • Use of any herbal product such as St John's Wort that may increase serotonin.
  • Use of monoamine oxidase inhibitors (MAOIs), pimozide or citalopram hydrobromide.
  • Drugs metabolized by CYP2D6 or a combination of CYP3A4 and CYP2D6 inhibitors.
  • Hypersensitivity to escitalopram or citalopram.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: escitalopram
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.
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 Names:
  • Lexapro
Placebo Comparator: placebo
Placebo tablets matched to drug.
Placebo tablets matched to drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Daily Symptom Rating Score.
Time Frame: baseline and 5 months.
A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.
baseline and 5 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Sheehan Disability Scale (SDS)
Time Frame: Throughout study
Throughout study
Patient Global Evaluation of Improvement (PGE)
Time Frame: Throughout treatment
Throughout treatment
Subject Satisfaction Questionnaire
Time Frame: Study endpoint
Study endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Ellen Freeman, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PMS

Clinical Trials on escitalopram

3
Subscribe