Status:
COMPLETED
Depressive Symptoms and Subjective Stress in the Course of the Menstrual Cycle - an Ambulatory Assessment Study.
Lead Sponsor:
Freie Universität Berlin
Conditions:
Major Depressive Episode
Eligibility:
FEMALE
18-45 years
Brief Summary
Background: Major changes in female sex hormone concentrations influence the development of depressive symptoms in women. This hypothesis has been thoroughly investigated with regard to the menopause...
Eligibility Criteria
Inclusion
- For participants with major depressive episode:
- Inclusion criteria:
- female sex
- current diagnosis of a major depression episode
- minimum age of 18 years
- regular menstrual cycle.
- Exclusion criteria:
- Pregnancy less than one year ago;
- women who are breastfeeding;
- bipolar disorder;
- acute suicidal tendencies;
- schizophrenic disorders (F20-29);
- substance use disorders
- psychotropic drugs in the last six months;
- chronic somatic diseases.
- For participants without major depressive episode:
- Inclusion criteria:
- female sex;
- minimum age of 18 years;
- regular menstrual cycle.
- Exclusion criteria:
- current or lifetime mental disorder;
- pregnancy less than one year ago;
- women who are breastfeeding;
- psychotropic drugs in the last six months;
- chronic somatic diseases.
Exclusion
Key Trial Info
Start Date :
January 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04086316
Start Date
January 15 2020
End Date
December 30 2022
Last Update
February 17 2023
Active Locations (1)
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1
Freie Universität Berlin
Berlin, Germany, 14195