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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
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 tablets matched to drug
Dept OB/GYN, Mudd Professorship Suite
Philadelphia, Pennsylvania, United States
Subject Daily Symptom Rating Score.
A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.
Time frame: baseline and 5 months.
Sheehan Disability Scale (SDS)
Time frame: Throughout study
Patient Global Evaluation of Improvement (PGE)
Time frame: Throughout treatment
Subject Satisfaction Questionnaire
Time frame: Study endpoint
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