Official Title: “Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2009

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 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.
• Placebo Comparator: 2
  • Placebo tablets matched to drug.

Primary Measures

• Subject daily symptom rating score.
  • Time Frame: Throughout study (~5 months).
    Safety Issue?: No
• Clinician global impressions (CGI score).
  • Time Frame: Throughout study
    Safety Issue?: No

Secondary Measures

• Sheehan Disability Scale (SDS)
  • Time Frame: Throughout study
    Safety Issue?: No
• Steiner Premenstrual Tension Scale (PMTS)
  • Time Frame: Throughout study
    Safety Issue?: No
• Patient Global Evaluation of Improvement (PGE)
  • Time Frame: Throughout treatment
    Safety Issue?: No
• Subject Satisfaction Questionnaire
  • Time Frame: Study endpoint
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pennsylvania

Overall Clinical Trial Officials and Contacts

Ellen Freeman Principal Investigator University of Pennsylvania  

Overall Contact: Naseem Kerr, MPH 215-662-3329 nkerr@mail.med.upenn.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00523705

Study ID Number: 805778

ClinicalTrials.gov Identifier: NCT00523705

Health Authority: United States: Food and Drug Administration