Anxiety and Depression in Adolescent PCOS

NCT ID: NCT07127458

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-17
• Study Completion Date: 2026-03-17

Brief Summary

Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder in adolescent females, often accompanied by psychological symptoms such as anxiety and depression. These conditions are frequently underdiagnosed and untreated. This study aims to determine the prevalence of anxiety and depression in adolescents with PCOS and to assess changes following oral contraceptive use.

Detailed Description

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age, characterized by heterogeneous complications. It is increasingly prevalent among adolescent females today. Women with PCOS may experience infrequent or prolonged menstrual periods, excessive hair growth, acne, and obesity. The rising prevalence of PCOS in the general population affects approximately 5-10% of women of reproductive age worldwide (1). A significant proportion of women with PCOS-particularly adolescent girls-experience major depressive disorder. Although the exact cause of PCOS remains unknown, early diagnosis and treatment, along with weight loss, can reduce the risk of long-term complications. Depression and anxiety are common in women with PCOS; however, their frequency has often been overlooked, leaving many cases untreated (2). In addition to physical symptoms, various mental health problems are also associated with PCOS (3). The diagnosis of PCOS is established when at least two of the following criteria are present: amenorrhea/oligomenorrhea, hyperandrogenism (clinical or biochemical), and a polycystic ovarian appearance on ultrasound (4). Psychosocial problems are particularly common among obese adolescents and those with excessive hair growth.

The rationale of this study is to investigate the prevalence of this often-overlooked comorbidity and to evaluate changes following OCS (oral contraceptive) use.

Conditions

PCOS (Polycystic Ovary Syndrome)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adolescents with Polycystic Ovary Syndrome

Adolescent patients with PCOS will be identified, and the prevalence of anxiety and depression will be assessed. Oral contraceptive therapy will be initiated, and patients will be re-evaluated after 6 months.

Group Type: EXPERIMENTAL

Adolescent PCOS group receiving oral contraceptives

Intervention Type: DRUG

Participants diagnosed with polycystic ovary syndrome (PCOS) during adolescence will receive a combined oral contraceptive (ethinylestradiol 30 µg + drospirenone 3 mg) once daily for six consecutive months. The intervention aims to regulate menstrual cycles, reduce hyperandrogenic symptoms, and evaluate changes in anxiety and depression scores over time.

Interventions

Adolescent PCOS group receiving oral contraceptives

Participants diagnosed with polycystic ovary syndrome (PCOS) during adolescence will receive a combined oral contraceptive (ethinylestradiol 30 µg + drospirenone 3 mg) once daily for six consecutive months. The intervention aims to regulate menstrual cycles, reduce hyperandrogenic symptoms, and evaluate changes in anxiety and depression scores over time.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 15 and 19 years
• Diagnosis of adolescent polycystic ovary syndrome (PCOS)

Exclusion Criteria

• Severe reading or comprehension difficulties
• Severe hearing impairment
• Current use of hormone therapy
• Presence of a virilizing tumor
• Major psychiatric disorders such as schizophrenia, bipolar disorder, or dissociative disorder

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Sabahattin Anıl Arı

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Izmir Bakircay University

Izmir, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sabahattin A Arı, Associate Professor

Role: CONTACT

s.anil.ari.md@gmail.com

+905547139994

Facility Contacts

Sabahattin A Arı, Associate Professor

Role: primary

s.anil.ari.md@gmail.com

+905547139994

Other Identifiers

A-PCOS-1

Identifier Type: -

Identifier Source: org_study_id