Stress & Premenstrual Symptoms Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Mood
- PMDD
- Stress
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only males
Description
Among women with PMDD (premenstrual mood dysphoric disorder), 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 physiolo...
Among women with PMDD (premenstrual mood dysphoric disorder), 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 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. CRF-enhanced startle is mediated by the bed nucleus of the stria terminalis (BNST). Thus, ALLO appears to impact the BNST and anxiety, versus the amygdala and acute fear. The proposed study will examine both anticipatory anxiety and cued fear at baseline and with SSRI treatment. The magnitude of the ASR with the former manipulation would reflect BNST activity which we hypothesize is dysregulated in women with PMDD. Secondary aims are to examine the impact of luteal phase treatment with a selective serotonin reuptake inhibitor (SSRI) on psychophysiology in women with PMDs and to examine the relationship between affective symptoms, stress regulation and immune function among these women, as well as associations with hormone levels and genetic markers.
Tracking Information
- NCT #
- NCT02777372
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Principal Investigator: Liisa Hantsoo, PhD Instructor