Phase 4
N=84
Stress & Premenstrual Symptoms Study
PMDD · Stress · Mood
Bottom Line
View on ClinicalTrials.gov: NCT02777372 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase — 54.2; 53.7; 56.4; 53.3 t score — p=0.139
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sertraline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase |
54.2; 53.7; 56.4; 53.3 | 0.139 |
| PRIMARY Impact of Sertraline on ASR Magnitude |
56.4; 53.3; 51.8; 52.2 | 0.843 |
| SECONDARY Interleukin 6 (IL-6) Level |
0.4; .34; .59; .4 | 0.06 |
| SECONDARY Tumor Necrosis Factor Alpha (TNF-alpha) Level |
1.27; 1.63; 1.27; 1.54 | — |
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:
- 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 Structured Clinical Interview for Diagnostic and Statistical Manual (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.
Data sourced from ClinicalTrials.gov (NCT02777372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.