Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety (PCOS)

October 4, 2022 updated by: Zhang Wei, Fudan University

Research on Risk Factors and Comprehensive Intervention Measures of Polycystic Ovary Syndrome Complicated With Mental Diseases Such as Depression and Anxiety

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • OB & GYN Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCOS treatment
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.
Drug: Oral Contraceptives, Combined
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.
Other Names:
  • Danie-35
  • Drospirenone and Ethinylestradiol Tablets (I)
  • Drospirenone and Ethinylestradiol Tablets (Ⅱ)
Drug: Metformin Pill
Metformin is used to lower insulin resistance or to modulate hyperinsulinism.
Other Names:
  • Metformin
Other: lifestyle intervention
Weight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: one year
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.
one year
Anxiety
Time Frame: one year
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.
one year
Health Related Quality of Life in PCOS
Time Frame: one year
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Director: Wei Zhang, Doctor, OB & GYN Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 24, 2021

First Submitted That Met QC Criteria

July 24, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FudanU2021-07-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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