Stress & Premenstrual Symptoms Study
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ClinicalTrials.gov Identifier: NCT02777372 |
Recruitment Status :
Recruiting
First Posted : May 19, 2016
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
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PMDD Stress Mood | Drug: Sertraline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 127 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Acoustic Startle Response in Women With Premenstrual Mood Disorders |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: Sertraline
To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMD group only) on arousal regulation across the menstrual cycle.
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Drug: Sertraline
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 LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
Other Name: Zoloft |
- ASR magnitude based on menstrual cycle phase. [ Time Frame: Baseline (day 1) and ends at 3 months ]During the luteal phase vs the follicular phase of the menstrual cycle in women with PMDs, compared to luteal and follicular ASR in healthy female controls. The startle response will be measured using the eyeblink reflex, measured by recording activity from the orbicularis oculi muscle. Recording will be performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. For the primary outcome of baseline ASR magnitude over the menstrual cycle, peak amplitude of the blink reflex will be determined in the 20-120-ms time frame following stimulus onset relative to baseline (baseline is the average baseline EMG level for the 50 ms immediately preceding auditory stimulus onset).
- Impact of Sertraline on ASR magnitude. [ Time Frame: During luteal phase of menstrual cycle during test day 3 ]To determine the impact of luteal phase treatment with an SSRI (PMD group only) on arousal regulation across the menstrual cycle. The startle response will be measured using the eyeblink reflex, measured by recording activity from the orbicularis oculi muscle. Recording will be performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. For the primary outcome of baseline ASR magnitude over the menstrual cycle, peak amplitude of the blink reflex will be determined in the 20-120-ms time frame following stimulus onset relative to baseline (baseline is the average baseline EMG level for the 50 ms immediately preceding auditory stimulus onset). Participants will return for test day 3 while on Sertraline and their ASR magnitude will be compared to their previous test days.
- CRP (C-Reactive Protein) [ Time Frame: Baseline (day 1) and ends at 3 months ]As there is an intimate relationship between HPA axis function, psychophysiology and psychoneuroimmunology, the investigators will collect blood samples to measure CRP (C-Reactive Protein) before and after the acoustic startle paradigm.
- IL-6 (Interleukin 6) [ Time Frame: Baseline (day 1) and ends at 3 months ]As there is an intimate relationship between HPA axis function, psychophysiology and psychoneuroimmunology, the investigators will collect blood samples to measure IL-6 (Interleukin 6) before and after the acoustic startle paradigm.
- TNF-alpha (Tumor necrosis factor ALPHA) [ Time Frame: Baseline (day 1) and ends at 3 months ]As there is an intimate relationship between HPA axis function, psychophysiology and psychoneuroimmunology, the investigators will collect blood samples to measure TNF-alpha (Tumor necrosis factor ALPHA) before and after the acoustic startle paradigm.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Participants must be:
- Aged 18 - 50 years, per self-report
- Able to give written informed consent, per self-report
- Fluent in written and spoken English
- Have normal or corrected to normal hearing and vision, per self-report
- Female participants must be experiencing regular menstrual cycles (24-39 days), per self-report
- Have a negative urine drug screen.
Exclusion Criteria:
Participants cannot have:
- Use of an psychotropic medication anytime in the past 2 months, per self-report
- Drug or alcohol abuse history within previous 2 years
- Lifetime history of psychotic disorder including, schizophrenia, schizoaffective disorder, major depression with psychotic features and bipolar disorder, per self-report
- Currently homeless, per self-report
- History of any Axis I disorder other then specific phobia within the past 12 months, per SCID interview
- Active suicidal ideation (suicide plan or suicide attempt) within the previous 6 months, per self-report
- Steroid hormone or hormonal contraceptive use in the past 6 months, per self-report, except emergency contraceptive use
- 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.
- Sensitive hearing, per self-report.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777372
Contact: Joanna Marks | 215-746-1157 | marksjoa@mail.med.upenn.edu | |
Contact: Liisa Hantsoo, PhD | 215-746-1156 | liisaha2@mail.med.upenn.edu |
United States, Pennsylvania | |
Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Joanna Marks, B.A. 215-746-1157 marksjoa@mail.med.upenn.edu | |
Contact: Liisa Hantsoo, PhD 215-746-1156 LiisaHa2@mail.med.upenn.edu | |
Principal Investigator: Liisa Hantsoo, PhD |
Principal Investigator: | Liisa Hantsoo, PhD | Instructor |
Publications:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02777372 |
Other Study ID Numbers: |
IRB00220794 1K23MH107831-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | May 19, 2016 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Zoloft PMS Menses |
Sertraline Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |