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

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PMS

Intervention: escitalopram (Drug); placebo (Other)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Ellen Freeman, Principal Investigator, Affiliation: University of Pennsylvania

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Subject Daily Symptom Rating Score.

Secondary outcome:

Sheehan Disability Scale (SDS)

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

Dept OB/GYN, Mudd Professorship Suite, Philadelphia, Pennsylvania 19104, United States
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: February 2008
Last updated: May 29, 2014

Page last updated: August 23, 2015

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