Actively Recruiting

Phase Not Applicable
Age: 25Years - 50Years
MALE
NCT05435222

Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders

Led by Andreas Walther · Updated on 2025-03-28

244

Participants Needed

1

Research Sites

137 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders

Who Can Participate

Age: 25Years - 50Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male sex
  • Age between 25 - 50 years
  • German speaking
  • Current major depression (assessed by SCID-5)
  • Informed consent as documented by signature
Not Eligible

You will not qualify if you...

  • 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 (except persistent depressive disorder and mild alcohol/substance use disorder)
  • Comorbidities of major depression with any other psychological disorder
  • Severe physical disorder requiring priority treatment
  • Diagnosed prostate cancer
  • Prostatic intraepithelial neoplasia (PIN)
  • Severe lower urinary tract symptoms
  • Untreated diagnosed sleep apnea
  • Current treatment with thyroid hormones, finasteride, antiepileptic drugs, anabolic compounds, hypnotic medication more than 2 nights/week, long-acting benzodiazepines, antipsychotic medication, or drugs affecting serum testosterone
  • Genetic or hormonal disorders including Klinefelter's syndrome, Cushing's disease, Addison's disease, or Hashimoto Thyroiditis

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich

Zurich, Canton of Zurich, Switzerland, 8032

Actively Recruiting

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Research Team

A

Andreas Walther, PhD

CONTACT

U

Ulrike Ehlert, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

6

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