NCT05435222: MSPP-MDD

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

Recruiting now NA Last updated 28 March 2025

What this trial tests

NA trial testing Male-specific psychotherapeutic program (MSPP) in Major Depressive Disorder in 244 participants. Currently enrolling.

Timeline

15 March 2023

Primary endpoint
1 October 2025

31 October 2025

Quick facts

Lead sponsor	Andreas Walther
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	244
Start date	15 March 2023
Primary completion	1 October 2025
Estimated completion	31 October 2025
Sites	1 location across Switzerland

Drugs / interventions tested

• Male-specific psychotherapeutic program (MSPP)
• Cognitive beahvioral therapy (CBT)

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Andreas Walther

Who can join

Adults 25 to 50, male only, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of a male-specific psychotherapeutic program for major depressive disorder compared to cognitive behavioral therapy and waitlist: study protocol for a six-arm randomized clinical superiority trial examining depressed eugonadal and hypogonadal men receiving testosterone
   Walther A, Ehlert U, Schneeberger M, Eggenberger L, et al · · 2023 · cited 7× · PMID 37415687 · DOI 10.3389/fpsyt.2023.1129386
2. Traditional masculinity ideologies are associated with psychiatric diagnoses in men.
   Schneeberger M, Ehlert U, Walther A. · · 2026 · PMID 41922435 · DOI 10.1038/s41598-026-45822-5
3. Problematic pornography use as an externalizing depression symptom in cisgender men: A cross-sectional questionnaire study.
   Walther A, Ehlert U, Komlenac N. · · 2025 · PMID 40920476 · DOI 10.1556/2006.2025.00070