Clinical trial NCT05307848: Reproductive Function in Women With Bipolar Disorder
Official title: Reproductive Function in Women With Bipolar Disorder: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Keywords: bipolar disorder
reproductive function
hormone
menstruation
cognition
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with bipolar disorder without medication, female patients with bipolar disorder after stable prescription for ≥6 months, and BMI-matched healthy controls

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 considerable disagreement about the causes of reproductive dysfunction in patients with bipolar disorder. This study will evaluate the reproductive function of female patients with bipolar disorder without medication and those with bipolar disorder after stable medication, compared with the health control. The purpose of the study is to explore the influence, degree, and possible risk factors of bipolar disorder itself and drugs on the reproductive function of female patients.

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 healthy controls. All of whom gave informed consent. All participants will be assessed and clinically examined at baseline, and all patients are encouraged to follow up in the sixth month. Baseline assessments will include demographics, menstrual records, comprehensive medical history, anthropometric measurements (weight and height), physical examination, pelvic ultrasound, and laboratory work (e.g., reproductive hormones). The follow-up of patients will include menstrual records, pelvic ultrasound, and reproductive hormones. Clinical symptoms will be assessed by Hamilton Depression Scale, Hamilton Anxiety Scale, and Young Mania Rating Scale at baseline and week 24. The cognitive function will be assessed at baseline and the sixth month with the Reusable Assessment of Neuropsychological Status Battery (RBANS) and the Stroop Color-Word Test. The primary outcomes will be menstruation, reproductive hormone levels, and pelvic ultrasound. Secondary outcomes will include overall psychiatric symptomatology, quality of life, cognitive function, and other biological data.

Eligibility criteria: Inclusion Criteria:

* Test groups：

  1. Subjects voluntarily participated in the trial and signed informed consent and were able to comply with planned visits, laboratory tests, and other study procedures；
  2. 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；
  3. First diagnosis of bipolar disorder or stable medication for ≥6 months.
* Control group：

  1. Subjects voluntarily participated in the trial and signed informed consent and were able to comply with planned visits, laboratory tests, and other study procedures；
  2. No history of mental illness;
  3. No history of psychotropic medication.

Exclusion Criteria:

1. Presence of any other medical disorder affecting reproductive endocrine function;
2. Taking contraceptives, immunosuppressants, and other drugs that may affect reproductive function within six months;
3. Currently pregnant, breastfeeding, or planning to become pregnant in perimenopause or postmenopause;
4. Those with obvious suicidal tendencies;
5. Serious neurological disease with a clear family history or underlying risk;
6. 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.

Primary outcomes:
measure: Changes in menstrual cycle at baseline and the sixth month
timeFrame: Baseline and the sixth month
measure: Changes in reproductive hormone at baseline and the sixth month
timeFrame: Baseline and the sixth month
measure: Changes in pelvic ultrasonography findings at baseline and the sixth month
timeFrame: Baseline and the sixth month
Secondary outcomes:
measure: Change of Hamilton Depression Scale (HAMD) from baseline to the sixth month
timeFrame: Baseline and the sixth month
measure: Change of Hamilton Anxiety Scale (HAMA) from baseline to the sixth month
timeFrame: Baseline and the sixth month
measure: Change of Young's Mania Scale (YMRS) from baseline to the sixth month
timeFrame: Baseline and the sixth month
measure: Change of Reusable Neuropsychological Status Assessment Battery (RBANS) from baseline to the sixth month
timeFrame: Baseline and the sixth month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute of 2nd Xiangya Hospital,CSU
Study officials:
References: