Premenstrual Hormonal and Affective State Evaluation (PHASE) Project (PHASE Project)

University of Illinois

Status: Completed

Conditions: Premenstrual Dysphoric Disorder

Treatments: Procedure: Individualized laboratory test

Study type: Interventional

Funder types: Other

Identifiers

NCT03862469

2018-1533

R21MH119642 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 129 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

All Participants

Other group

Treatment:

Procedure: Individualized laboratory test