Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of sertraline in reducing symptoms in women
      diagnosed with premenstrual dysphoric disorder.
    

Detailed description: 
      Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS). PMDD
      affects nearly 5 percent of menstruating women in the United States. This disorder is very
      disruptive and can affect a woman's performance at work and her relationships with friends
      and family. Symptoms typically occur 10 to 14 days before the start of a woman's period and
      dissipate soon after. Sadness, rapid changes in mood, anxiety, and irritability are common
      symptoms associated with PMDD. Sertraline is a selective serotonin reuptake inhibitor (SSRI)
      that has been approved by the U.S. Food and Drug Administration (FDA) to treat PMDD. This
      study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed
      with PMDD.

      All participants will begin this study by recording their symptoms for two complete menstrual
      cycles. At a baseline study visit, participants will then be randomly assigned to receive
      either sertraline or placebo for six menstrual cycles. At the onset of PMDD symptoms,
      participants will take two pills of their assigned treatment daily. Once symptoms have
      dissipated, usually around the first or second day of the menstrual cycle, participants will
      stop taking their assigned treatment for that cycle. For the next 4 months, participants will
      attend study visits on the fifth day of each monthly menstrual cycle. For the following 2
      months, participants will be contacted by telephone. Participants will be asked to rate their
      mood and symptoms at each contact. A final study visit will be scheduled on the first day of
      the seventh menstrual cycle. At this point, all participants will be offered sertraline for
      an additional three menstrual cycles, dosed on a daily basis. Two study visits will be
      scheduled over the course of the three cycles to evaluate the effectiveness of sertraline
      when dosed continuously. Urine collection and pregnancy tests may occur at selected times
      during the study.
    

Intervention name(s): Sertraline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.; 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
Other intervention name(s): Zoloft; Placebo, sugar pill
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premenstrual Syndrome