Precision Medicine in the Depression Treatment

Recruiting now

Conditions studied: Depressive Disorder, Major, Treatment Outcome, Cognitive Dysfunction, Cognitive Behavioral Therapy, Antidepressive Agents

In brief

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.

Key facts

Study ID

NCT05616559

Run by

Rigshospitalet, Denmark

People needed

800

Starts

2021-06-15

Expected to finish

2026-12-01

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Neurobiology Research Unit, Rigshospitalet — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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