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.
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.
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
The Capital Region of Denmark is the most urban area of Denmark and has a population of 1.6 million people. Patients in the Capital Region of Denmark are referred from their general practitioner or other treatment providers for treatment within the mental health services in the region. All six clinics in the region provide treatment packages for first-episode depression.
Cohort
Prospective
Treatment Package for First-Episode Depression
Combination productThe 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.
Clinical remission
Quick Inventory of Depressive Symptomatology (QIDS) score of ≤5
Clinical improvement
≥50% reduction in QIDS score.
Changes in depression severity
Changes in depression severity by QIDS (range from 0 to 27, higher score indicating greater severity)
Changes in symptomatology
Changes on the Brief Symptom Inventory 18 (BSI-18, range 0-72, higher score indicating greater psychological distress)
Changes in depression and anxiety symptomatology
Changes on the 10-item depression and anxiety symptom checklist (SCL-10, range 0-100 higher score indicating greater symptomatology)
Change in wellbeing
Changes measured by the WHO-5 well-being Index (range 0-100, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being).
Medication side-effects
Patient Reported Inventory of Side-Effects (PRISE)
Adverse and unwanted events in psychotherapy
Negative Effects Questionnaire (NEQ) to assess adverse and unwanted events in psychological treatment
Psychosocial remission
Defined as either a WHO-5 score of \>49, an SCL-10 score of \<26 or an mSDS score of \<10.
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Rigshospitalet, Denmark
Lead sponsor
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Collaborator
Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak
Collaborator
Lundbeck Foundation
Collaborator
