NCT05435222 Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders
| NCT ID | NCT05435222 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Andreas Walther |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 244 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 244 participants in total. It began in 2023-03-15 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project aims to evaluate a male-specific psychotherapeutic program (MSPP) for MDD based on cognitive behavioral therapy (CBT). The primary goal is to test the superiority of the MSPP. This will be conducted in two groups of depressed men, namely eudonadal depressed men and hypogonadal depressed men receiving testosterone treatment (TT). In a randomized study design, the MSPP will be compared to a standard CBT and a waitlist control group, resulting in a total of six study groups. Both standardized psychotherapy programs will encompass 18 sessions delivered in a weekly manner, starting at study week 6 and continuing until study week 24. Aligned with the TT-related medical visits of the hypogonadal men, all participants will be followed up with clinical assessments and biosampling at weeks 0, 6, 15, 24, 36. In addition, a separate healthy control group will be examined, which will undergo only baseline assessments.
Eligibility Criteria
Inclusion Criteria: 1. Male sex 2. Age between 25 - 50 years 3. German speaking 4. Current major depression (assessed by SCID-5) 5. Informed consent as documented by signature Exclusion Criteria: 1. Inability to give informed consent 2. Prior hormonal (testosterone) treatment 3. Prior mental health disorder 4. Current or previous psychopharmacological treatment 5. Current or previous psychological treatment for any psychological disorder \- Exception for persistent depressive disorder (Dysthymia) and alcohol/substance use disorder of mild degree (SCID-5, 1 - 3 criteria met) 6. Comorbidities of major depression with any other psychological disorder 7. Severe physical disorder that requires priority treatment 8. Any of the following physical conditions, particularly relevant in regard to testosterone treatment: * Diagnosed prostate cancer * Prostatic intraepithelial neoplasia (PIN) * Severe lower urinary tract symptoms * Erythrocytosis Sleep apnea, diagnosed but untreated 9. Current treatment with: * Thyroid hormones * Finasteride * Antiepileptic drugs * Anabolic compounds * Hypnotic medication more than 2 nights/week for the treatment of insomnia * Long-acting benzodiazepines * Antipsychotic medication * Drugs that affect serum testosterone 10. Genetic / hormonal disorders: * Klinefelter's syndrome * Cushing's disease * Addison's disease * Hashimoto Thyroiditis
Contact & Investigator
Andreas Walther, PhD
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT05435222 clinical trial?
This trial is open to male participants only, aged 25 Years or older, up to 50 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05435222 currently recruiting?
Yes, NCT05435222 is actively recruiting participants. Contact the research team at a.walther@psychologie.uzh.ch for enrollment information.
Where is the NCT05435222 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT05435222 clinical trial?
NCT05435222 is sponsored by Andreas Walther. The principal investigator is Andreas Walther, PhD at University of Zurich. The trial plans to enroll 244 participants.