Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This
      study compares short-term treatment (4 months) and long-term treatment (12 months) with
      sertraline to determine how long medication should be continued after achieving a good
      response, how soon symptoms return after stopping medication, and whether symptoms are
      further improved with long-term treatment. Multiple hypotheses include the following: The
      percent of relapsed subjects is greater with short-term treatment; relapse is swifter with
      short-term treatment; relapsed subjects improve swiftly when returned to medication; patient
      satisfactions and quality of life are more improved with long-term treatment.
    

Detailed description: 
      Severe PMS is a chronic and complex mood disorder that involves mood, behavioral and physical
      symptoms linked to the menstrual cycle with severity that disrupts functioning for as much as
      several weeks each menstrual cycle. Estimates indicate that 20-25% of menstruating women
      experience severe PMS. The efficacy of serotonergic antidepressants is clearly demonstrated
      for severe forms of PMS in short-term treatment trials. This study compares short-term
      treatment (4 months) and long-term treatment (12 months) with sertraline in a randomized,
      placebo-controlled design. The purpose is to determine how long medication should be
      continued following symptom relief, to what extent and how rapidly symptoms return after
      stopping medication, and whether there is any additional improvement with long-term
      treatment.

      Following a screen period for 2-3 menstrual cycles that includes a placebo-treated cycle,
      eligible women are randomized double-blind to the short-term or long-term treatment arm.
      Subjects are switched (double-blind) to placebo after 4 months or 12 months of sertraline
      treatment. All subjects continue the study for a total of 21 months and receive either
      sertraline or the matching placebo in this interval. Subjects whose symptoms return are given
      open-label sertraline without breaking the study blind. Subjects rate symptoms daily
      throughout the study using the Penn Daily Symptom Report. Other assessments are conducted at
      monthly intervals and include the Clinical Global Impressions Rating Scale, Sheehan
      Disability Scale, Hamilton Depression Rating Scale, Endicott Quality of Life Questionnaire
      and the Cohen Perceived Stress Scale. The overall duration of the study is expected to be 5-6
      years.
    

Intervention name(s): sertraline
Intervention type(s): Drug
Intervention description(s): 50 - 100 mg daily for 2 weeks before each menses for 4 months or 12 months and then switched to placebo.
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PMS; PMDD; sertraline; antidepressant; extended treatment; relapse