NCT07474363

Brief Summary

Depression is a common and serious mental health condition that affects mood, thoughts, behavior, and overall quality of life. It arises from a complex interaction of biological, psychological, and environmental factors. While depression is more frequently diagnosed in women, research suggests that men may experience and express depressive symptoms differently. Men are more likely to display symptoms such as irritability, anger, impulsivity, or increased alcohol use, and they may be less likely to seek professional psychological support due to social expectations and fear of stigma. Stigma-both self-stigma (internalized negative beliefs about having a mental illness) and perceived social stigma (concerns about being judged by others)-can negatively influence individuals' willingness to seek help and adhere to treatment. In addition, psychological resilience, defined as the ability to cope effectively with stress and adversity, may play an important role in how individuals experience depressive symptoms and respond to treatment. This study aims to compare women and men diagnosed with Major Depressive Disorder in terms of depression severity, gender-sensitive depressive symptoms, self-stigma, perceived social stigma, and levels of psychological resilience. It will also examine the relationships among these factors to better understand how gender-related differences influence the experience and management of depression. Findings from this study may contribute to improved recognition of gender-specific features of depression, reduction of stigma, and the development of more individualized and effective mental health interventions for both women and men.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jun 2025Nov 2026

Study Start

First participant enrolled

June 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 11, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Depression Severity

    Depression severity will be assessed using the Beck Depression Inventory (BDI). The Beck Depression Inventory is a 4-point Likert-type scale consisting of 21 items. Each item is rated on a scale of 0 to 3, and the total possible score ranges from 0 to 63. Higher scores indicate a greater severity of depressive symptoms.

    Baseline (single assessment)

  • Gender Differences in Gender-Sensitive Depressive Symptoms

    Gender-sensitive depressive symptom severity will be assessed using the Gender-Sensitive Depression Scale, a 24-item, four-point Likert-type instrument. Each item is rated on a four-point scale with response options ranging from 0 to 3: "Never or rarely," "Sometimes," "Often," and "Always." The scale comprises the subdimensions of Dysphoria-Irritability, Impulsivity-Shame, and Alcohol Use. Higher scores indicate greater severity of depressive symptoms.

    Baseline (single assessment)

Secondary Outcomes (3)

  • Self-Stigma in Depression

    Baseline (single assessment)

  • Perceived Social Stigma Related to Seeking Psychological Help

    Baseline (single assessment)

  • Psychological Resilience

    Baseline (single assessment)

Study Arms (2)

Women

Female patients aged 18-65 years who were diagnosed with Major Depressive Disorder and presented to the Psychiatry Outpatient Clinic of Eskişehir Osmangazi University Faculty of Medicine

Men

Male patients aged 18-65 years who were diagnosed with Major Depressive Disorder and presented to the Psychiatry Outpatient Clinic of Eskişehir Osmangazi University Faculty of Medicine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who presented to the Department of Psychiatry Outpatient Clinic at Eskişehir Osmangazi University Faculty of Medicine.

You may qualify if:

  • Male and female patients aged 18 to 65 years
  • Diagnosis of Major Depressive Disorder according to DSM-5 at the time of study participation
  • Provision of voluntary informed consent

You may not qualify if:

  • Intellectual disability
  • Severe neurological disorders
  • Comorbid psychiatric diagnoses
  • Depressive disorder secondary to an organic medical condition
  • Depressive disorder secondary to substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Department of Psychiatry Outpatient Clinic at Eskişehir Osmangazi University Faculty of Medicine

Eskişehir, Eskişehir, 26040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorSocial Stigma

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersSocial BehaviorBehavior

Central Study Contacts

İrem OZKAYNAK DAGLİ, Research assistant, M.D.

CONTACT

HARUN O SONKURT, Asst. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

June 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data collected in the study will be shared. This will include demographic variables (e.g., age, gender, education level, marital status), clinical variables related to Major Depressive Disorder, and scale scores obtained from the study instruments. Specifically, the dataset will contain participants' scores on depression severity measures, gender-sensitive depression symptom scales, psychological resilience scales, and stigma measures used in the study. All shared data will be anonymized and will not include any information that could directly identify individual participants.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The de-identified individual participant data and supporting materials will be made available beginning 6 months after publication of the study results. The data will remain available for a period of 5 years following publication.
Access Criteria
Describe who will be able to access the IPD and supporting information, what they will be able to access, and how they will be able to access it.

Locations