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Recruiting
NCT05616559
Precision Medicine in the Depression Treatment
Conditions: Depressive Disorder, Major, Treatment Outcome, Cognitive Dysfunction, Cognitive Behavioral Therapy, Antidepressive Agents
Sex: All
Ages: 18 Years – 65 Years
Enrollment: 800
Sponsor: Rigshospitalet, Denmark
Location: Denmark
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 Criteria
Inclusion Criteria:Age between 18 and 65 yearsFulfilment 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 symptomsHistory of severe head traumaSomatic disease associated with morphological brain changes (e.g., brain tumour)Insufficient Danish language skills to complete questionnaires and cognitive testingAdditional exclusion criteria for Cohort II:Severe somatic diseaseContraindications for MRI (e.g., metal implants, claustrophobia or back problems)Additional exclusion criteria for Cohort III:Severe somatic diseaseContraindications for MRIExposure to radioactivity >10 mSv within the last yearPregnancy or breastfeedingUse of psychotropic drugs
Source: ClinicalTrials.gov (NCT05616559). StuddyBuddy aggregates publicly available trial information.