NCT05435222Recruiting
Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders
Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders Compared to Standard Cognitive Behavioral Therapy: a Randomized Controlled Superiority Trial
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- First submitted
- 14 Sept 2020
- Start date
- 15 Mar 2023
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Andreas Walther
- Diseases
- Depression
- NCT number
- NCT05435222
What you commit to
- Study type: Interventional
- Planned participants: 244
- From 15 Mar 2023 to the primary completion date, 1 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
- Genetic / hormonal disorders:
- Klinefelter's syndrome
- Cushing's disease
- Addison's disease
- Hashimoto Thyroiditis
Lab values
- 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
Other
- Inability to give informed consent
Who the study is looking for
- Male sex
- Age between 25 - 50 years
- German speaking
- Current major depression (assessed by SCID-5)
- Informed consent as documented by signature
Age in the registry: 25 years to 50 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.