NCT05307848

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 14, 2022

Last Update Submit

March 24, 2022

Conditions

Bipolar Disorder

Keywords

bipolar disorderreproductive functionhormonemenstruationcognition

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Change of Hamilton Depression Scale (HAMD) from baseline to the sixth month

    Baseline and the sixth month

  • Change of Hamilton Anxiety Scale (HAMA) from baseline to the sixth month

    Baseline and the sixth month

  • Change of Young's Mania Scale (YMRS) from baseline to the sixth month

    Baseline and the sixth month

  • Change of Reusable Neuropsychological Status Assessment Battery (RBANS) from baseline to the sixth month

    Baseline and the sixth month

Study Arms (3)

Female patients with bipolar disorder without medication

Other: No intervention

Female patients with bipolar disorder after stable prescription for ≥6 months

Other: No intervention

Age and BMI-matched healthy controls

Other: No intervention

Interventions

No interventionOTHER

No intervention

Age and BMI-matched healthy controlsFemale patients with bipolar disorder after stable prescription for ≥6 monthsFemale patients with bipolar disorder without medication

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Institute of 2nd Xiangya Hospital,CSU

Changsha, 410001, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Central Study Contacts

Jindong Chen, M.D. Ph.D

CONTACT

+8613807319266chenjindong@csu.edu.cn

Jing Huang, M.D. Ph.D

CONTACT

jinghuangserena001@csu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 1, 2022

Study Start

March 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

CN(1)