Stress & Premenstrual Symptoms Study

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a pilot 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 male and 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, cortisol, and immune markers, as well as hormone and genetic measures. Female participants with PMDs will receive sertraline during the premenstrual phase.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University; University of Pennsylvania
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Sertraline

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 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.