Premenstrual syndrome and premenstrual dysphoric disorder
Conditions
Interventions
None listed
Sponsors
Shiga University of Medical Science
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patient and family member/partner who have come to our hospital during the study period and meet all of the following criteria. [PMS/PMDD patient] 1. Agrees to be treated for PMS/PMDD 2. Has PMS/PMDD symptoms according to DSR and Sheehan Disability Scale (SDISS) (Pre-menstrual SDR score of 80 and above, score is increased by more than 50% of the post-menstrual score, and meets 1 or more items in SDISS) 3. Is above 20 years old and under 40 years old at the time of agreement 4. Has a regular menstrual cycle (Menstrual cycle is between 25 and 38 days and fluctuation is 7 days or less, duration of bleeding is within 7 days and fluctuation is 2 days or less) 5. Has a family member/partner who has lived in the same household for more than 3 months prior to agreement to participate in the study, who plans to live in the same household until the end of the study, and who is willing to attend the outpatient sessions 6. Is able to sign the agreement form by free will (both the patient and family member/partner) [Family member/partner] 1. Is a family member/partner of the patient who meets the inclusion criteria
Exclusion criteria
Exclusion criteria: [PMS/PMDD patient] 1. Meets the diagnostic criteria of schizophrenia, depression, or drug/medication-induced depression according to DSM-5 or has a history of mania episode and meets the diagnostic criteria for bipolar disorder 2. Requires continued intake of oral contraceptives and/or other hormonal agents 3. Requires steroids and/or other anti-inflammatory medications 4. Possess hypothyroidism, Cushing Disease, systemic lupus erythematosus or any other disease which has risk for depressive symptoms 5. Any patients whom the study staff or investigator find inappropriate to include in the study [Family member/partner] None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PMS/PMDD symptoms assessed by Penn Daily Symptom Report (DSR) score. Subjective change in symptoms, improvements in understanding of disease, subjective change in communication with family member/partner at the end of the study period. Change in EE of family member/partner assessed by Five Minute Speech Sample (FMSS) since first assessment. | — |
Countries
Japan
Contacts
Public ContactKenichi Kuriyama
Shiga University of Medical Science Department of Psychiatry
Outcome results
None listed