Reproductive Function in Women With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Reproductive Function in Women With Bipolar Disorder: a Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307848
• Other study ID #: RF20220301
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2022
• Source: Central South University
• Contact: Jindong Chen, M.D. Ph.D
• Phone: +8613807319266
• Email: chenjindong[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Mental Health Institute of 2nd Xiangya Hospital,CSU	Changsha

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in menstrual cycle at baseline and the sixth month		Baseline and the sixth month
Primary	Changes in reproductive hormone at baseline and the sixth month		Baseline and the sixth month
Primary	Changes in pelvic ultrasonography findings at baseline and the sixth month		Baseline and the sixth month
Secondary	Change of Hamilton Depression Scale (HAMD) from baseline to the sixth month	Scores ranging from 0-75, with higher scores indicating more severe symptoms	Baseline and the sixth month
Secondary	Change of Hamilton Anxiety Scale (HAMA) from baseline to the sixth month	Scores ranging from 0-56, with higher scores indicating more severe symptoms	Baseline and the sixth month
Secondary	Change of Young's Mania Scale (YMRS) from baseline to the sixth month	Scores ranging from 0-60, with higher scores indicating more severe symptoms	Baseline and the sixth month
Secondary	Change of Reusable Neuropsychological Status Assessment Battery (RBANS) from baseline to the sixth month	Scores ranging from 0-321, with higher scores indicating better cognitive ability	Baseline and the sixth month