Status:
RECRUITING
Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders
Lead Sponsor:
Andreas Walther
Conditions:
Major Depressive Disorder
Eligibility:
MALE
25-50 years
Phase:
NA
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 b...
Detailed Description
Background: Although women are twice as likely to suffer from major depressive disorder (MDD) than men, there are still over 100 million men affected by this condition worldwide. Unfortunately, men su...
Eligibility Criteria
Inclusion
- Male sex
- Age between 25 - 50 years
- German speaking
- Current major depression (assessed by SCID-5)
- Informed consent as documented by signature
Exclusion
- Inability to give informed consent
- Prior hormonal (testosterone) treatment
- Prior mental health disorder
- Current or previous psychopharmacological treatment
- 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)
- Comorbidities of major depression with any other psychological disorder
- Severe physical disorder that requires priority treatment
- 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
- 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
- Genetic / hormonal disorders:
- Klinefelter's syndrome
- Cushing's disease
- Addison's disease
- Hashimoto Thyroiditis
Key Trial Info
Start Date :
March 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT05435222
Start Date
March 15 2023
End Date
October 31 2025
Last Update
March 28 2025
Active Locations (1)
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1
Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich
Zurich, Canton of Zurich, Switzerland, 8032