Reproductive Function in Women With Bipolar Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Jindong Chen, M.D. Ph.D; Phone Number: +8613807319266; Email: chenjindong@csu.edu.cn
• Study Contact Backup: Name: Jing Huang, M.D. Ph.D; Email: jinghuangserena001@csu.edu.cn

Study Locations

• China
  • Changsha, China, 410001
    • Recruiting
    • Mental Health Institute of 2nd Xiangya Hospital,CSU
    • Contact: Jing Huang, PhD; Phone Number: 15874290980; Email: jinghuangserena001@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Female patients with bipolar disorder without medication	Other: No intervention; No intervention
Female patients with bipolar disorder after stable prescription for ≥6 months	Other: No intervention; No intervention
Age and BMI-matched healthy controls	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in menstrual cycle at baseline and the sixth month	Baseline and the sixth month
Changes in reproductive hormone at baseline and the sixth month	Baseline and the sixth month
Changes in pelvic ultrasonography findings at baseline and the sixth month	Baseline and the sixth month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: cognition; bipolar disorder; hormone; menstruation; reproductive function
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder
• Other Study ID Numbers: RF20220301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes