menopausal disorder with psychological symptoms
Conditions
Interventions
After informed consent is obtained, patients are registered provisionally, and are orally administered
2 placebo capsules a day, each after breakfast and supper, for 2 weeks. Those who did not respond
D011733
Sponsors
Terauchi Masakazu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [provisional registration] Those who fulfill all the items below will be registered provisionally: 1. those who have menopausal disorder with psychological symptoms by main doctor(excluding those who have symptoms due to cancer treatment) 2. those who responded as either moderate or severe to any of the MHR-QOL items: #10 I feel less enthusiastic about things than before.; #11 Things I used to enjoy have become a bit of chore.; #12 I do less than I would like.; #16 I upset about small things.; #17 I feel nervous about small things. 3. those who are aged 40 to 64 years old 4. out-clinic patients 5. female 6. those how are able to provide informed consent [definite registration] Those who fulfill the inclusion criteria item #2 after 2 weeks of placebo administration will be registered definitely.
Exclusion criteria
Exclusion criteria: Those who fulfill any of the items below will be excluded from the trial. 1. those who have depressive disorders not related to menopause 2. those who have serious comorbidities, such as cancers, cardiac diseases, liver diseases, hematologic diseases, etc. 3.those who were enrolled in another trial less than three months ago, or those who are going to be enrolled in another trial during the course of the current one 4. those who were prescribed any of the incompatible drugs (estrogens, Kampo formulae, psychotropic agents, etc.) within the past 4 weeks 5. those who have serious drug allergy 6. those whose eGFR are less than 30 mL/min 7. Patients on medication for hyperthyroidism and hypothyroidism 8. those whom the principal investigator or co-investigators consider to be incompatible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in depressive symptoms (decrease in the CES-D score at week 6 compared to week 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in vasomotor symptoms (decrease in the Hot Flash Severity Index from week 0 to week 6) Improvement in anxiety symptoms (decrease in the STAI score from week 0 to week 6) | — |
Contacts
Public ContactMasakazu Terauchi
Institute of Science Tokyo Hospital
Outcome results
None listed