Precision Medicine in the Depression Treatment
The BrainDrugs-Depression Study: A Prospective Precision Psychiatry Cohort Study in the Treatment of Depression
Rigshospitalet, Denmark
800 participants
Jun 15, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria11
- 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
- Severe somatic disease
- Contraindications for MRI (e.g., metal implants, claustrophobia or back problems)
- Severe somatic disease
- Contraindications for MRI
- Exposure to radioactivity \>10 mSv within the last year
- Pregnancy or breastfeeding
- Use of psychotropic drugs
Interventions
The outpatient 'treatment package' for first episode depression is a national uniform package designed by Mental Health Services in the Capital Region. The treatment package for first-episode depression is a program with manualized group CBT, psychoeducation of patients and relatives, and relapse prevention. Antidepressant medication and individual psychotherapy are available as needed.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05616559