Premenstrual Dysphoric Disorder
Conditions
Brief summary
PHASE is designed to evaluate neuroactive hormone trajectories across the menstrual cycle and endocrine, autonomic, and subjective responses to psychosocial stress in women suffering from severe PMS (i.e., premenstrual dysphoric disorder).
Detailed description
Female volunteers will be recruited from the community for participation in this 3-menstrual cycle study. In the first two menstrual cycles, study participants will chart their symptoms and and ovulation. Study participants will continue to perform ovulation testing during their third menstrual cycle in which they will attend one individualized task session and provide 8 serum samples at different timepoints across the menstrual cycle. Primary analyses will contrast neuroactive hormone trajectories across the menstrual cycle and stress reactivity according to study groups (PMDD vs healthy).
Interventions
PROCEDUREIndividualized laboratory test
Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.
Sponsors
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Aged 18-35 years, established by visual inspection of a government-issued ID * Average menstrual cycle 21-35 days
Exclusion criteria
* Lifetime DSM-5 Axis 1 disorder (except anxiety and depression), as documented in the Mental Health Interview * Current DSM-5 Axis depressive or anxiety disorder, as documented in the Mental Health Interview * Positive urine drug screen test * Breath alcohol concentration \>0.00% * Self-reported smoker or carbon monoxide concentration ≥ 6 ppm * Irregular menstrual cycle * Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant * Moderate or high suicide risk * Shipley IQ (vocabulary standard score) \> 80 * Any prescription medications (including hormonal forms of birth control)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hormone Analysis | -20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle) | Cortisol |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PMDD PMDD patients | 15 |
| Controls Healthy Controls | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | PMDD | Controls | Total |
|---|---|---|---|
| Age, Continuous | 26.0 years STANDARD_DEVIATION 4.8 | 26.36 years STANDARD_DEVIATION 5.1 | 26.2 years STANDARD_DEVIATION 5 |
| Age of Menarche | 11.4 years STANDARD_DEVIATION 1.71 | 12.0 years STANDARD_DEVIATION 1.54 | 11.8 years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 9 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Hormone Analysis
Cortisol
Time frame: -20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PMDD Patients | Hormone Analysis | +30 minute timepoint | 111 ng/mL | Standard Deviation 43.6 |
| PMDD Patients | Hormone Analysis | +50 minute timepoint | 86.9 ng/mL | Standard Deviation 39.4 |
| PMDD Patients | Hormone Analysis | +20 minute timepoint | 114 ng/mL | Standard Deviation 53.4 |
| PMDD Patients | Hormone Analysis | +65 minute timepoint | 73.5 ng/mL | Standard Deviation 31.6 |
| PMDD Patients | Hormone Analysis | +40 minute timepoint | 97 ng/mL | Standard Deviation 48.9 |
| PMDD Patients | Hormone Analysis | +90 minute timepoint | 70.6 ng/mL | Standard Deviation 36.6 |
| PMDD Patients | Hormone Analysis | -20 minute timepoint | 70.7 ng/mL | Standard Deviation 26.4 |
| Healthy Controls | Hormone Analysis | +90 minute timepoint | 69 ng/mL | Standard Deviation 18.5 |
| Healthy Controls | Hormone Analysis | -20 minute timepoint | 57.8 ng/mL | Standard Deviation 21.9 |
| Healthy Controls | Hormone Analysis | +20 minute timepoint | 97.3 ng/mL | Standard Deviation 39.9 |
| Healthy Controls | Hormone Analysis | +30 minute timepoint | 109 ng/mL | Standard Deviation 43.6 |
| Healthy Controls | Hormone Analysis | +40 minute timepoint | 100 ng/mL | Standard Deviation 32.4 |
| Healthy Controls | Hormone Analysis | +50 minute timepoint | 93.3 ng/mL | Standard Deviation 29.2 |
| Healthy Controls | Hormone Analysis | +65 minute timepoint | 78.4 ng/mL | Standard Deviation 24 |