Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders
Recruiting · NCT05435222 · Interventional (participants receive a specific treatment) · Lead sponsor: Andreas Walther
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Male sex
- Age between 25 - 50 years
- German speaking
- Current major depression (assessed by SCID-5)
- Informed consent as documented by signature
Exclusion criteria
- 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
Where it is running
1 location listed.
- Ambulatory for Cognitive Behavioral Therapy and Behavioral Medicine of the University of Zurich - Zurich, Canton of Zurich, Switzerland