Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Information source: University of Pennsylvania
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premenstrual Syndrome
Intervention: escitalopram (Drug); placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s):
Ellen Freeman, Principal Investigator, Affiliation: University of Pennsylvania
Overall contact:
Naseem Kerr, MPH, Phone: 215-662-3329, Email: nkerr@mail.med.upenn.edu
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.
Clinical Details
Official title: Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Subject daily symptom rating score.Clinician global impressions (CGI score).
Secondary outcome: Sheehan Disability Scale (SDS)Steiner Premenstrual Tension Scale (PMTS) Patient Global Evaluation of Improvement (PGE) Subject Satisfaction Questionnaire
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.
Eligibility
Minimum age: 15 Years.
Maximum age: 19 Years.
Gender(s): Female.
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.
Locations and Contacts
Naseem Kerr, MPH, Phone: 215-662-3329, Email: nkerr@mail.med.upenn.edu
University of Pennsylvania, Dept Ob/Gyn, 3701 Market St, Suite 820 (Mudd), Philadelphia, Pennsylvania 19104, United States; Recruiting
Cheryl Irving, AB, Phone: 215-662-3329, Email: cirving@mail.med.upenn.edu
Ellen W Freeman, PhD, Principal Investigator
Additional Information
Related publications: Vichnin M, Freeman EW, Lin H, Hillman J, Bui S. Premenstrual syndrome (PMS) in adolescents: severity and impairment. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):397-402.
Starting date: January 2008
Ending date: July 2009
Last updated: March 14, 2008
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