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DepressionIODOEDPENCT07627477

Impact of Depression Severity on Sexual Dysfunction

An observational study of Depression and Erectile Dysfunction, run by Sohag University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Assess the relationship and the prevalence…" "To determine the prevalence of erectile dysfunction and premature ejaculation among depressed male patients and evaluate their association with depression severity." Read more about this study

Who is it for?
Ages 25 to 60 years, men only
How many people
100 participants
Where
1 siteEgypt
Study dates
1 May 2026to 1 Jun 2027
How long will I take part?
2 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Study population: Male married patients diagnosed with depressive disorder according to DSM5

Who may be able to join

  • Married male pt aged 25_60yrs
  • Clinically diagnosed with depressive disorder DSM5
  • sexually active in the past 6 months

Who cannot join

  • pts with major medical or neurological disorders known to be impaired sexual activity
  • History of substance use disorder
  • Pts receiving medications known to cause sexual Dysfunction except antidepressants
  • Pts with primary sexual Dysfunction prior to the onset of Depression

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Sohag faculty of medicine

    Sohag

Other trials in Egypt

About this study

Official title: Impact of Depression Severity on Erectile Dysfunction and Premature Ejaculation in Male Patients in Sohag Governorate A Clinical Assessment in Sohag Psychiatric Population

Assess the relationship and the prevalence…" "To determine the prevalence of erectile dysfunction and premature ejaculation among depressed male patients and evaluate their association with depression severity."

Read the detailed description

# Detailed Study Procedure and Assessment Description

All participants included in this study will undergo a comprehensive psychiatric, psychosocial, medical, and sexual health assessment using a structured clinical interview conducted by trained psychiatry residents under the supervision of senior psychiatric staff at Sohag University Hospitals and Sohag Psychiatric Hospital. The assessment process will begin after explaining the purpose, objectives, confidentiality measures, and voluntary nature of participation to each participant, followed by obtaining informed written consent. Each participant will then be assigned an anonymous identification code to maintain privacy and confidentiality throughout all stages of data collection, analysis, and reporting. The interview will be conducted in a private and comfortable clinical setting to ensure accurate disclosure of sensitive sexual and psychological information and to minimize embarrassment, social desirability bias, or fear of stigma. Sociodemographic information will first be collected including age, residence, educational level, occupation, socioeconomic status, religion, duration of marriage, number of children, marital stability, and living arrangements. Additional marital and relationship-related data will also be obtained including quality of marital communication, emotional intimacy, presence of ongoing marital conflicts, spouse awareness of depressive symptoms, and the impact of sexual dysfunction on marital satisfaction and emotional bonding. Information regarding occupational stress, financial stressors, caregiving burdens, and family-related psychosocial difficulties will also be documented because of their potential influence on both depressive symptoms and sexual functioning.

A detailed psychiatric history will then be obtained from every participant. This assessment will include age at onset of depressive symptoms, duration of illness, pattern and course of depressive episodes, precipitating psychosocial stressors, previous psychiatric admissions, history of suicidal ideation or suicide attempts, family history of psychiatric disorders, and previous psychiatric treatments including antidepressant medications, psychotherapy, electroconvulsive therapy, or combined treatment approaches. Special emphasis will be placed on antidepressant medication history, particularly selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and atypical antidepressants because of their possible association with sexual dysfunction. Drug dosage, duration of treatment, adherence, and temporal relationship between medication initiation and onset of sexual symptoms will be carefully explored. The severity of depressive symptoms will be assessed using the Hamilton Depression Rating Scale (HAM-D), Arabic version, which is a validated clinician-administered scale widely used to quantify depressive symptom severity. The HAM-D assessment will be performed by trained clinicians to ensure standardization and reliability of scoring. The scale evaluates multiple domains including depressed mood, guilt feelings, suicidal thoughts, insomnia, psychomotor retardation, agitation, anxiety symptoms, somatic symptoms, and impairment in work and daily activities. Based on total HAM-D scores, patients will be categorized into mild, moderate, severe, or very severe depression groups for further statistical analysis and comparison.

A detailed sexual history will subsequently be obtained in a respectful, confidential, and nonjudgmental manner. Participants will be asked about age at onset of sexual activity, frequency of sexual intercourse, level of sexual desire, quality of erections, ejaculation timing, sexual satisfaction, performance anxiety, and changes in sexual activity following the onset of depressive symptoms. Assessment of erectile dysfunction will include onset, duration, severity, progression, and whether symptoms are generalized or situational. Questions regarding morning erections and nocturnal erections will be included to help differentiate psychogenic from possible organic components of erectile dysfunction. Assessment of premature ejaculation will include estimated intravaginal ejaculatory latency time, degree of voluntary control over ejaculation, associated distress, frustration, interpersonal difficulties, and avoidance of sexual intimacy. Participants will also be asked about previous medical consultations for sexual dysfunction, prior pharmacological or behavioral treatments, and perceived effects of sexual dysfunction on self-esteem, masculinity, confidence, and marital relationship quality.

To objectively evaluate erectile dysfunction, the International Index of Erectile Function-5 (IIEF-5), Arabic validated version, will be administered to all participants. The IIEF-5 is a self-reported questionnaire designed to assess erectile confidence, erection firmness, maintenance ability, intercourse satisfaction, and overall erectile function during the previous six months. According to established cut-off scores, participants will be classified into no erectile dysfunction, mild, mild-to-moderate, moderate, or severe erectile dysfunction categories. Similarly, premature ejaculation will be assessed using the Premature Ejaculation Diagnostic Tool (PEDT), Arabic validated version. The PEDT is a standardized self-administered questionnaire that evaluates ejaculatory control, frequency of rapid ejaculation, distress associated with ejaculation timing, interpersonal difficulties, and overall satisfaction with sexual performance. Based on PEDT scoring, participants will be classified as having no premature ejaculation, probable premature ejaculation, or definite premature ejaculation. The use of validated Arabic versions of both assessment tools aims to improve reliability, cultural appropriateness, and participant comprehension.

Comprehensive medical and neurological history taking will also be performed to identify possible confounding factors associated with sexual dysfunction. Particular attention will be directed toward chronic medical illnesses known to impair sexual functioning including diabetes mellitus, hypertension, ischemic heart disease, chronic kidney disease, chronic liver disease, obesity, metabolic syndrome, endocrine disorders, thyroid dysfunction, benign prostatic hyperplasia, and neurological diseases such as stroke, epilepsy, multiple sclerosis, spinal cord disorders, or peripheral neuropathy. History of smoking, alcohol intake, substance abuse, caffeine intake, physical activity level, sleep quality, and dietary habits will also be documented because of their possible relationship with depressive symptoms and sexual health. Current and previous medications other than antidepressants will be reviewed carefully to exclude medications known to contribute to erectile dysfunction or premature ejaculation such as antihypertensive agents, antipsychotics, antiepileptic drugs, hormonal therapies, and recreational substances. Participants with primary sexual dysfunction predating depressive illness or with severe uncontrolled medical conditions significantly affecting sexual performance will be excluded from the study according to the exclusion criteria.

A focused physical and mental state examination will be carried out for all participants. Mental state examination will include assessment of appearance, behavior, speech, mood, affect, thought process, thought content, cognition, insight, and judgment. Assessment for psychotic symptoms, anxiety manifestations, obsessive symptoms, and substance misuse will also be conducted to identify psychiatric comorbidities that may influence sexual functioning or depressive severity. When clinically indicated, laboratory investigations may be requested including fasting blood glucose, HbA1c, liver function tests, kidney function tests, thyroid function tests, serum testosterone levels, prolactin levels, and lipid profile to exclude endocrine or metabolic contributors to sexual dysfunction. These investigations will not be mandatory for all participants but may be performed in selected cases according to clinical judgment.

All collected data will be entered into a coded electronic database and analyzed using the Statistical Package for Social Sciences (SPSS). Quantitative variables will be presented as means and standard deviations, while qualitative variables will be presented as frequencies and percentages. Comparative statistical analyses will be performed to determine the prevalence of erectile dysfunction and premature ejaculation among depressed patients and to evaluate the relationship between severity of depression and severity of sexual dysfunction. Correlation analyses will be used to assess the strength and direction of associations between HAM-D scores, IIEF-5 scores, and PEDT scores. Multivariate analyses may also be performed to control for confounding variables such as age, smoking status, chronic medical diseases, duration of marriage, and antidepressant use. Statistical significance will be considered at a p-value less than 0.05.

Throughout the study, all ethical principles related to biomedical research involving human participants will be strictly followed. Participants will have the full right to refuse participation or withdraw from the study at any stage without affecting their access to medical care. Confidentiality and anonymity will be maintained by storing data securely and restricting access only to the research team. Because the study addresses sensitive sexual and psychiatric topics, participants experiencing severe depressive symptoms, suicidal thoughts, severe marital distress, or significant untreated sexual dysfunction will be referred for appropriate psychiatric or sexual health management whenever needed. The findings of this study are expected to provide valuable information regarding the prevalence and severity of erectile dysfunction and premature ejaculation among depressed male patients in Sohag Governorate and may contribute to improving early detection, comprehensive psychiatric assessment, and integrated management strategies addressing both depression and sexual health in psychiatric practice.

Keywords
Depression severity, Depression, Premature Ejaculation, Erectile Dysfunction
Medical subject headings
Depression, Erectile Dysfunction, Premature Ejaculation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Depression severity in premature Ejaculation patients

    Depression severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D-17), a clinician-administered instrument widely used to evaluate depressive symptoms. The total score ranges from 0 to 52, with higher scores indicating greater severity of depression. Scores will be analyzed to determine the relationship between depression severity and the occurrence and severity of premature ejaculation among male psychiatric patients using premature Ejaculation severity scale PEDS Interpretation of HAM-D 0-7: Normal 8-16: Mild depression 17-22: Moderate depression

    • 23: Severe depression Scoring of PEDS ≤ 8: No PE 9-10: Probable PE
    • 11: PE likely present Higher scores indicate greater severity of premature ejaculation.

    Measured: 6 months

  2. Assessment of Depression severity in Erectile Dysfunction patients

    Depression severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D-17), a clinician-administered instrument widely used to evaluate depressive symptoms. The total score ranges from 0 to 52, with higher scores indicating greater severity of Depression.Scores will be analyzed to determine the relationship between depression severity and the occurrence and severity of Erectile Dysfunction among male psychiatric patients using the 5-item International Index of Erectile Function (IIEF-5), . Total scores range from 5 to 25, with lower scores indicating more severe erectile dysfunction.

    Interpretation of HAM-D 0-7: Normal 8-16: Mild depression 17-22: Moderate depression

    ≥23: Severe depression Interpretation of IIEF 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start1 May 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07627477
Sponsor's protocol ID
Soh-Med-26-4-7MS
Acronym
IODOEDPE
Status last verified
May 2026
First submitted
7 May 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Erectile Dysfunction, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Depression severity in premature Ejaculation patients (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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