Stress & Premenstrual Symptoms Study

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Mood; PMDD; Stress

Treatments: Drug: Sertraline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02777372

1K23MH107831-01A1 (U.S. NIH Grant/Contract)

IRB00220794

Details and patient eligibility

About

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.

Full description

Among women with premenstrual mood dysphoric disorder (PMDD), baseline arousal is heightened during the luteal phase of the menstrual cycle compared to the follicular phase, as measured by acoustic startle response (ASR). Healthy female controls do not show cyclic changes in this measure of physiologic arousal. It has been suggested that such heightened physiologic arousal during the luteal phase may be due to differences in neurosteroid modulation of Gamma-aminobutyric acid (GABA)-A receptor function. Research indicates that women with premenstrual mood disorders (PMDs) may have sub-optimal sensitivity to the progesterone metabolite allopregnanolone (ALLO), a GABA-A receptor modulator. In animal models, intracerebroventricular injection of corticotrophin releasing factor (CRF) increases amplitude of the acoustic startle response, while ALLO administration attenuates this CRF-enhanced startle. The primary aim of this study is to examine differences in ASR by menstrual cycle phase (follicular, luteal) and group (control, PMDD). Secondary aim is to examine the impact of luteal phase treatment with a selective serotonin reuptake inhibitor (SSRI) on psychophysiology in women with PMDs. An exploratory aim is to examine immune function among these women.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Sertraline

Experimental group

Description:

To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMDD group only) on acoustic startle response across the menstrual cycle. Sertraline 50 mg tablets are administered daily from ovulation until menses onset.

Treatment:

Drug: Sertraline

Control

No Intervention group

Description:

No intervention.