Precision Medicine in the Depression Treatment
Recruiting · NCT05616559 · Observational (researchers observe without assigning treatment) · Lead sponsor: Rigshospitalet, Denmark
View the official record on ClinicalTrials.gov →Interventions studied
Treatment Package for First-Episode Depression
What this trial is about
The BrainDrugs-D study uses multimodal neuroimaging combined with self-report measures, clinical and molecular markers to identify clinically relevant predictors that can identify subtypes of major depressive disorder (MDD) and, in a naturalistic setting, predict treatment response to standard antidepressive treatment. The cohorts are followed in nationwide health registries.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age between 18 and 65 years
- Fulfilment of International Classification of Diseases version 10 diagnostic criteria for a primary depressive episode (i.e., not secondary to known organic or other psychiatric disorder).
- Referral to a treatment package for single-episode depression.
Exclusion criteria
- Psychosis or psychotic symptoms
- History of severe head trauma
- Somatic disease associated with morphological brain changes (e.g., brain tumour)
- Insufficient Danish language skills to complete questionnaires and cognitive testing
- Additional exclusion criteria for Cohort II:
- Severe somatic disease
- Contraindications for MRI (e.g., metal implants, claustrophobia or back problems)
- Additional exclusion criteria for Cohort III:
- Severe somatic disease
- Contraindications for MRI
- Exposure to radioactivity \>10 mSv within the last year
- Pregnancy or breastfeeding
- Use of psychotropic drugs
Where it is running
1 location listed.
- Neurobiology Research Unit, Rigshospitalet - Copenhagen, Denmark