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

NCT04984070 | Unknown

• 1 other identifier: FudanU2021-07-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Depression, Anxiety

Keywords

polycystic ovary syndrome; depression; anxiety; bipolar disorder; intervention

Outcome Measures

Primary Outcomes (3)

• 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.

  one year

• 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.

  one year

• 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.

  one year

Study Arms (1)

PCOS treatment

EXPERIMENTAL

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; Drug: Metformin Pill; Other: lifestyle intervention

Interventions

Oral Contraceptives, Combined DRUG

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.

Also known as: Danie-35, Drospirenone and Ethinylestradiol Tablets (I), Drospirenone and Ethinylestradiol Tablets (Ⅱ)

PCOS treatment

Metformin Pill DRUG

Metformin is used to lower insulin resistance or to modulate hyperinsulinism.

Also known as: Metformin

PCOS treatment

lifestyle intervention OTHER

Weight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients

PCOS treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• Any other related diseases, such as adrenal congenital hyperplasia, Cushing's syndrome, androgen-secreting tumors, Hashimoto's thyroiditis, hyperthyroidism or hypothyroidism

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Depression; Anxiety Disorders; Bipolar Disorder

Interventions

Contraceptives, Oral, Combined; drospirenone; Ethinyl Estradiol; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Wei Zhang, Doctor

  OB & GYN Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Hexia Xia, Doctor

CONTACT

13601843476; xhx0101@hotmail.com

Wei Zhang, Doctor

CONTACT

13611699901; zhangwei623@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 30, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

CN (1)