Actively Recruiting
Led by Rigshospitalet, Denmark · Updated on 2024-10-08
800
Participants Needed
1
Research Sites
N/A
Total Duration
R
Rigshospitalet, Denmark
Lead Sponsor
M
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Collaborating Sponsor
Researchers are studying major depressive disorder (MDD) in adults to identify subtypes of the condition and predict how patients respond to standard antidepressant treatments. This observational study uses a combination of neuroimaging, self-report measures, clinical evaluations, and molecular markers. The study includes patients receiving care within mental health services and follows them through nationwide health registries to gather comprehensive data. Participants receive a standardized treatment package for first-episode depression that includes group cognitive-behavioral therapy (CBT), psychoeducation for patients and relatives, medication clinics, and relapse prevention. The study has three groups: a main cohort of 800 patients with clinical and biological data, a subgroup of 600 patients with additional MRI and EEG scans, and a smaller group of 60 unmedicated patients who also undergo PET imaging to measure brain synaptic density. Throughout the study, participants complete questionnaires assessing depression severity, functioning, quality of life, and side effects at multiple follow-up points up to 18 months. Researchers use these data to measure clinical remission and improvement six months after treatment begins, along with longer-term outcomes. Advanced statistical and machine learning methods will help understand patient characteristics, treatment effects, and clinical outcomes over time.
CONDITIONS
Precision Medicine in the Depression Treatment
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants who undergo routine care are observed while receiving a standardized treatment package for first-episode depression consisting of group CBT, psychoeducation, relapse prevention, and medication or individual psychotherapy as needed. Data on clinical, cognitive, psychometric, genetic, biochemical, and imaging assessments are collected before treatment begins.
Questionnaires at baseline, 6, 12, and 18 months; treatment visits as per clinical practice
Duration - Up to 18 months after treatment start
Participants are followed through nationwide health registries and periodic assessments to evaluate long-term clinical outcomes including remission and symptom changes.
Questionnaires at 12 and 18 months follow-up
Total: 1 location
1
Neurobiology Research Unit, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
K
Kristian HR Jensen, MD
M
Martin B Jørgensen, DMSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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