Stress & Premenstrual Symptoms Study
Condition: PMDD; Stress; Mood
Intervention: Sertraline
Intervention description: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine luteinizing hormone (LH) Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Zoloft; premenstrual syndrome (PMS); Menses

Summary:

      This study that aims to evaluate the psychophysiology of premenstrual mood disorders (PMDs)
      at baseline and after treatment with sertraline. Participants will include women with PMDs
      and healthy female controls. Participation involves a baseline visit to determine eligibility
      and three study visits that include questionnaires and stress reactivity assessment via an
      acoustic startle paradigm. Female participants with PMDs will receive sertraline during the
      premenstrual phase.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants must be:

          1. Aged 18 - 50 years, per self-report

          2. Able to give written informed consent, per self-report

          3. Fluent in written and spoken English

          4. Have normal or corrected to normal hearing and vision, per self-report

          5. Female participants must be experiencing regular menstrual cycles (24-39 days), per
             self-report

          6. Have a negative urine drug screen.

        Exclusion Criteria:

        Participants cannot have:

          1. Use of an psychotropic medication anytime in the past 2 months, per self-report

          2. Drug or alcohol abuse history within previous 2 years

          3. Lifetime history of psychotic disorder including, schizophrenia, schizoaffective
             disorder, major depression with psychotic features and bipolar disorder, per
             self-report

          4. Currently homeless, per self-report

          5. History of any Axis I disorder other then specific phobia within the past 12 months,
             per Structured Clinical Interview for Diagnostic and Statistical Manual (SCID)
             interview

          6. Active suicidal ideation (suicide plan or suicide attempt) within the previous 6
             months, per self-report

          7. Steroid hormone or hormonal contraceptive use in the past 6 months, per self-report,
             except emergency contraceptive use

          8. Pregnancy in the past year, per self-report. Pregnancy during the study is also
             exclusionary. Participants must use a reliable, nonhormonal form of birth control
             during the study. If a participant becomes pregnant, she must inform study staff.

          9. Sensitive hearing, per self-report.