Status:
UNKNOWN
Reproductive Function in Women With Bipolar Disorder
Lead Sponsor:
Central South University
Conditions:
Bipolar Disorder
Eligibility:
FEMALE
16-40 years
Brief Summary
Many studies have shown that patients with bipolar disorder are prone to reproductive dysfunction, including polycystic ovary syndrome, hyperprolactinemia, and amenorrhea. However, there is still cons...
Detailed Description
This study will comprise 60 female patients with bipolar disorder without medication, 60 female patients with bipolar disorder after stable prescription for ≥6 months, and 60 age and BMI-matched healt...
Eligibility Criteria
Inclusion
- Test groups：
- Subjects voluntarily participated in the trial and signed informed consent and were able to comply with planned visits, laboratory tests, and other study procedures；
- Meets the diagnostic criteria for bipolar disorder in the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) and has no coexisting psychiatric disorders；
- First diagnosis of bipolar disorder or stable medication for ≥6 months.
- Control group：
- Subjects voluntarily participated in the trial and signed informed consent and were able to comply with planned visits, laboratory tests, and other study procedures；
- No history of mental illness;
- No history of psychotropic medication.
Exclusion
- Presence of any other medical disorder affecting reproductive endocrine function;
- Taking contraceptives, immunosuppressants, and other drugs that may affect reproductive function within six months;
- Currently pregnant, breastfeeding, or planning to become pregnant in perimenopause or postmenopause;
- Those with obvious suicidal tendencies;
- Serious neurological disease with a clear family history or underlying risk;
- Combining other severe acute or chronic diseases, mental diseases, or abnormal laboratory tests has clinical significance, and the subject is judged by the investigator to be unsuitable to participate in this study.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05307848
Start Date
March 1 2021
End Date
February 28 2023
Last Update
April 1 2022
Active Locations (1)
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1
Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, China, 410001