Identifying predictors for treatment response in major depression
The BrainDrugs-Depression Study: A Prospective Precision Psychiatry Cohort Study in the Treatment of Depression
This study is trying to find out what factors can help predict how well different treatments will work for people with major depression.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05616559 on ClinicalTrials.gov |
What this trial studies
The BrainDrugs-D study focuses on patients with major depressive disorder (MDD) by utilizing multimodal neuroimaging techniques alongside self-report measures and clinical data to identify subtypes of MDD and predict treatment responses. Participants will undergo a thorough phenotyping process before receiving a standardized treatment package that includes cognitive-behavioral therapy and medication management. The study aims to recruit 800 patients and will follow them in nationwide health registries to assess treatment outcomes in a naturalistic setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with a primary depressive episode and are referred for standard treatment.
Not a fit: Patients with psychosis, severe head trauma, or significant somatic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for individuals suffering from major depressive disorder.
How similar studies have performed: Other studies utilizing neuroimaging to predict treatment response in depression have shown promise, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Neurobiology Research Unit, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Martin B Jørgensen, DMSc — Psychiatric Center Copenhagen
- Study coordinator: Kristian HR Jensen, MD
- Email: kristian.reveles.jensen@nru.dk
- Phone: +45 35456720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.