Recruiting

Precision Medicine in the Depression Treatment

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.

ClinicalTrials.gov IDNCT05616559

PhaseNot Applicable

Enrollment800

SponsorCopenhagen University Hospital, Rigshospitalet

Age18 Years – 65 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Combination Product: Treatment Package for First-Episode Depression — 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.

Primary outcomes

Clinical remission (Baseline to 6 months after treatment start)
Clinical improvement (Baseline to 6 months after treatment start)

Eligibility information

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

Study locations

Neurobiology Research Unit, Rigshospitalet, Copenhagen, 2100 Denmark

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.