Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety (PCOS)
Primary Purpose
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Depression, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oral Contraceptives, Combined
Metformin Pill
lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries focused on measuring polycystic ovary syndrome, depression, anxiety, bipolar disorder, intervention
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed as PCOS according to Rotterdam criteria 2003, aged between 18 and 40 years old, and no willing to get pregnant in a year.
At least two of the following three criteria were met: clinical and/or biochemical signs of hyperandrogenism, oligo- and/or anovulation, and polycystic ovary on ultrasonography,
Exclusion Criteria:
- Any other related diseases, such as adrenal congenital hyperplasia, Cushing's syndrome, androgen-secreting tumors, Hashimoto's thyroiditis, hyperthyroidism or hypothyroidism
Sites / Locations
- OB & GYN Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PCOS treatment
Arm Description
Lifestyle intervention, oral contraceptive pills and metformin will be given to improve the symptoms of PCOS patients, such as obesity, hyperandrogegism, and insulin resistance, and to compare the different psychological status in PCOS.
Outcomes
Primary Outcome Measures
Depression
The self-rating depression scale(SDS) is assessed before and after intervention. The SDS score multiplied by 1.25 is a standard score, which is between 25-100. A score no less than 50 is consider as depression.
Anxiety
The self-rating anxiety scale(SAS) is assessed before and after intervention. The SAS score multiplied by 1.25 is a standard score, which is between 25-100. A score no less than 50 is consider as anxiety.
Health Related Quality of Life in PCOS
The scores of Health Related Quality of Life Questionnaire are assessed before and after treatment, which range from 30 to 210. Higher scores indicate higher quality of life of PCOS patients with less influence from PCOS.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04984070
Brief Title
Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety
Acronym
PCOS
Official Title
Research on Risk Factors and Comprehensive Intervention Measures of Polycystic Ovary Syndrome Complicated With Mental Diseases Such as Depression and Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study intends to establish a prediction method and evaluation system for polycystic ovary syndrome (PCOS) complicated with affective disorder, such as depression and anxiety, through the epidemiological investigation. Randomized controlled studies on the efficacy of various intervention methods should be carried out to develop early intervention measures and methods in order to reduce the harm of psychological disorders, to facilitate the mental health of PCOS patients, and thus to improve the quality of life.
Detailed Description
PCOS is one of the most common reproductive endocrine and metabolic diseases in women of adolescence and childbearing age. The prevalence of PCOS in reproductive women is as high as 5-10%, about 50-80% of whom are infertile and need ovulation induction or in vitro fertilization-embryo transfer (IVF-ET). Ovulation/anovulation and hyperandrogenemia are two main features of PCOS. Moreover, about 50-60% of PCOS patients present insulin resistance/hyperinsulinemia. The probability of miscarriage in PCOS is also higher than that of control women. Pregnancy complications in PCOS patients, such as gestational diabetes, preeclampsia, etc., and long-term complications of metabolic syndrome and endometrial cancer are more likely to happen. These not only greatly affect women's reproductive health, but also seriously endanger their psychological status. A large sample of data has shown that the risk of depression in women with PCOS is 3.78 times higher than that of the control women, 5.62 times for anxiety, and 1.78 times for bipolar disorder. With the economic development, more and more attention is paid to the quality of life including their mental health. However, there is few data on the risk factors of depression, anxiety and other psychological disorders in women with PCOS. There is a lack of effective evaluation and prediction systems. It is urgent to establish a risk assessment system for PCOS complicated with psychological diseases through scientific and systematic research, to formulate comprehensive intervention measures to improve the quality of life of women with PCOS and to reduce the incidence of affective disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Depression, Anxiety
Keywords
polycystic ovary syndrome, depression, anxiety, bipolar disorder, intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCOS treatment
Arm Type
Experimental
Arm Description
Lifestyle intervention, oral contraceptive pills and metformin will be given to improve the symptoms of PCOS patients, such as obesity, hyperandrogegism, and insulin resistance, and to compare the different psychological status in PCOS.
Intervention Type
Drug
Intervention Name(s)
Oral Contraceptives, Combined
Other Intervention Name(s)
Danie-35, Drospirenone and Ethinylestradiol Tablets (I), Drospirenone and Ethinylestradiol Tablets (Ⅱ)
Intervention Description
One of the three medications like ethinylestradiol (35 μg) and cyproterone acetate, drospirenone and ethinylestradiol tablets (I) and (Ⅱ) will be used as an antiandrogen.
Intervention Type
Drug
Intervention Name(s)
Metformin Pill
Other Intervention Name(s)
Metformin
Intervention Description
Metformin is used to lower insulin resistance or to modulate hyperinsulinism.
Intervention Type
Other
Intervention Name(s)
lifestyle intervention
Intervention Description
Weight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients
Primary Outcome Measure Information:
Title
Depression
Description
The self-rating depression scale(SDS) is assessed before and after intervention. The SDS score multiplied by 1.25 is a standard score, which is between 25-100. A score no less than 50 is consider as depression.
Time Frame
one year
Title
Anxiety
Description
The self-rating anxiety scale(SAS) is assessed before and after intervention. The SAS score multiplied by 1.25 is a standard score, which is between 25-100. A score no less than 50 is consider as anxiety.
Time Frame
one year
Title
Health Related Quality of Life in PCOS
Description
The scores of Health Related Quality of Life Questionnaire are assessed before and after treatment, which range from 30 to 210. Higher scores indicate higher quality of life of PCOS patients with less influence from PCOS.
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed as PCOS according to Rotterdam criteria 2003, aged between 18 and 40 years old, and no willing to get pregnant in a year.
At least two of the following three criteria were met: clinical and/or biochemical signs of hyperandrogenism, oligo- and/or anovulation, and polycystic ovary on ultrasonography,
Exclusion Criteria:
Any other related diseases, such as adrenal congenital hyperplasia, Cushing's syndrome, androgen-secreting tumors, Hashimoto's thyroiditis, hyperthyroidism or hypothyroidism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hexia Xia, Doctor
Phone
13601843476
Email
xhx0101@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhang, Doctor
Phone
13611699901
Email
zhangwei623@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Doctor
Organizational Affiliation
OB & GYN Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
OB & GYN Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hexia Xia, Doctor
Phone
13601843476
Email
hexia_xia@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Hexia Xia, Doctor
First Name & Middle Initial & Last Name & Degree
Haiyun Guan, Doctor
First Name & Middle Initial & Last Name & Degree
Rongmin Wang, Master
First Name & Middle Initial & Last Name & Degree
Zhijing Tang, PhD student
12. IPD Sharing Statement
Learn more about this trial
Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety
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