Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Intervention: Sertraline; Placebo
Intervention description: 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.
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 252.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Premenstrual Syndrome

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Menstruating and has cycles between 21 and 35 days

          -  Meets DSM-IV criteria for PMDD

          -  Experienced symptoms of PMDD in at least 9 of 12 menstrual cycles within 1 year of
             study entry

          -  Willing to use an effective form of birth control throughout the study

        Exclusion Criteria:

          -  Meets MINI DSM-IV criteria for major depressive episode, substance abuse, bulimia
             nervosa, anorexia, bipolar disorder, or a psychotic disorder, such as schizophrenia or
             schizoaffective disorder, within 6 months of study entry

          -  Meets MINI DSM-IV criteria for a substance dependence disorder within 12 months of
             study entry

          -  Shows follicular phase symptoms consistent with a diagnosis of major depression

          -  Shows symptoms consistent with bipolar disorder

          -  Diagnosed with a severe, clinically significant co-existing condition that may prevent
             study participation

          -  Suicidal

          -  Taking ongoing antidepressant or other psychotropic medication

          -  History of hypersensitivity or an adverse reaction to sertraline

          -  Pregnant or breastfeeding

          -  Currently undergoing treatment with a depot hormonal preparation or any other
             medication that would lead to a lack of menses or markedly irregular menses

          -  Using a hormonal contraceptive pill or hormonal device within 6 months of study entry

          -  Taking a hormonal contraceptive pill that includes 20 micrograms of ethinyl estradiol
             and 3 micrograms of drospirenone

          -  Has been in individual psychotherapy or individual counseling for 3 months or less at
             study entry