Sertraline Treatment for PMS / Premenstrual Dysphoric Disorder (PMDD)
Dr. Kimberly Yonkers
What is the purpose of this trial?
This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder who only take medication when their symptoms begin and stop within 3 days of menses.
Study Status: Ongoing
Who can participate?
Ages Eligible: 18-48 Years
Gender Eligible: Female
Have regular menstrual periods
Experience PMS/PMDD symptoms every month
Not currently depressed or taking prescription anti-depressant or anti-anxiety medication
Not planning to become pregnant in the next 12 months
Using a reliable form of birth control
Description of Trial:
Will conduct a brief phone interview to determine preliminary eligibility and then offer to schedule and office visit. Eligibility determined by participants’ monthly charting of menstrual symptoms for 2 cycles. After qualifying, participants are randomly assigned to receive either sertraline or placebo for six menstrual cycles.
At the onset of PMDD symptoms, participants take study medication. Once symptoms dissipate, participants stop medication. For the next 4 months, participants attend monthly visits. For 2 months, participants are contacted by telephone. Participants rate their mood and symptoms daily. At the final visit, participants are offered sertraline for three more menstrual cycles, dosed daily.
Participants attend 2 more study visits over 3 months to evaluate the effectiveness of sertraline when dosed continuously.
Study HIC #: 0609001839
For more information, click here
Study Contact: Kari Van Steenburg; Telephone: 203-764-5719
