Overview
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Status:
Terminated
Terminated
Trial end date:
2009-10-01
2009-10-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of PennsylvaniaCollaborator:
Forest LaboratoriesTreatments:
Citalopram
Dexetimide
Criteria
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.