Anxiety and Depression in Adolescent PCOS | NCT07127458

Studies
Anxiety and Depression in Adolescent PCOS

NCT07127458

Sponsor

Ege University

Status

Completed

Last Update Posted

Mar 25, 2026Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

PCOS (Polycystic Ovary Syndrome)

Interventions

Adolescent PCOS group receiving oral contraceptives

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2025Actual

Primary Completion Date

Mar 17, 2026Actual

Completion Date

Mar 17, 2026Actual

First Submitted Date

Aug 11, 2025

First Submission Date that Met QC Criteria

Aug 11, 2025

First Posted Date

Aug 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2026

Last Update Posted Date

Mar 25, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sabahattin Anıl Arı, Associate Professor, Ege UniversityPrincipal Investigator

Lead Sponsor

Ege UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adolescents with Polycystic Ovary Syndrome	Experimental	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.	Drug: Adolescent PCOS group receiving oral contraceptives

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adolescent PCOS group receiving oral contraceptives	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Beck Depression Inventory	Change in Beck Depression Inventory Score After 6 Months of Oral Contraceptive Use	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Izmir Bakircay University		Izmir		35665	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided