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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: PMS

In brief

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.

Key facts

Study ID

NCT00523705

Run by

University of Pennsylvania

People needed

11

Starts

2008-02-01

Expected to finish

2009-10-01

Last updated by the study team

2014-06-06

Who can join

Age: 15 and older, up to 19. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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