Bipolar DisorderNCT05307848
Reproductive Function in Women With Bipolar Disorder
An observational study of Bipolar Disorder, run by Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 28 Feb 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jing Huang, M.D. Ph.D contact
China1 site, 1 recruiting
- Recruiting
Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, 410001
Jing Huang, PhD, 15874290980, jinghuangserena001@csu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- No intervention
- Keywords
- bipolar disorder, reproductive function, hormone, menstruation, cognition
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Female patients with bipolar disorder without medication | Not described Receives: Other: No intervention | |
| Female patients with bipolar disorder after stable prescription for ≥6 months | Not described Receives: Other: No intervention | |
| Age and BMI-matched healthy controls | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in menstrual cycle at baseline and the sixth month
Measured: Baseline and the sixth month
Changes in reproductive hormone at baseline and the sixth month
Measured: Baseline and the sixth month
Changes in pelvic ultrasonography findings at baseline and the sixth month
Measured: Baseline and the sixth month
Secondary outcomes (4)
Change of Hamilton Depression Scale (HAMD) from baseline to the sixth month
Scores ranging from 0-75, with higher scores indicating more severe symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and the sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Mar 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307848
- Sponsor's protocol ID
- RF20220301
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Function in Women With Bipolar Disorder: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05307848
- Acronym / sponsor ID
- RF20220301
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, reproductive function, hormone, menstruation, cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (8 listed)
- Test groups：
- Control group：
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Age and BMI-matched healthy controls, Female patients with bipolar disorder after stable prescription for ≥6 months, Female patients with bipolar disorder without medication |
Primary outcome
Changes in menstrual cycle at baseline and the sixth month
Time frame: Baseline and the sixth month
Changes in reproductive hormone at baseline and the sixth month
Time frame: Baseline and the sixth month
Changes in pelvic ultrasonography findings at baseline and the sixth month
Time frame: Baseline and the sixth month
4 secondary outcomes
Change of Hamilton Depression Scale (HAMD) from baseline to the sixth month
Time frame: Baseline and the sixth month
Change of Hamilton Anxiety Scale (HAMA) from baseline to the sixth month
Time frame: Baseline and the sixth month
Change of Young's Mania Scale (YMRS) from baseline to the sixth month
Time frame: Baseline and the sixth month
Change of Reusable Neuropsychological Status Assessment Battery (RBANS) from baseline to the sixth month
Time frame: Baseline and the sixth month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Huang, M.D. Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jindong Chen, M.D. Ph.D (+8613807319266, chenjindong@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in menstrual cycle at baseline and the sixth month (time frame: Baseline and the sixth month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.