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Search / Trial NCT05616559

Precision Medicine in the Depression Treatment

Launched by RIGSHOSPITALET, DENMARK · Nov 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pet Mri F Mri Eeg Prediction Of Treatment Response Early Life Stress Selective Serotonin Reuptake Inhibitor Psychometrics Mdd Cold Cognition Social Cognition Anxiety

ClinConnect Summary

The BrainDrugs-D study is investigating how different factors can help predict which treatments will work best for people with major depressive disorder (MDD). By using advanced brain imaging techniques, along with questionnaires and medical tests, the researchers want to understand the different types of depression and how patients respond to standard treatments like therapy and medication. This study aims to improve treatment outcomes by identifying specific characteristics that might indicate how well someone will respond to a particular treatment.

To participate, individuals need to be between 18 and 65 years old and must have a diagnosis of a primary depressive episode, meaning their depression is not caused by another medical or psychiatric condition. Participants will be asked to complete various assessments and may undergo brain scans as part of the study. The research team is looking for volunteers, and they will ensure that those with certain conditions, like severe head injuries or certain medical issues, are not included to keep everyone safe. If you or someone you know is interested in learning more, this study could help shape future treatments for depression.

Gender

ALL

Eligibility 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

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Copenhagen, , Denmark

Patients applied

0 patients applied

Trial Officials

Martin B Jørgensen, DMSc

Principal Investigator

Psychiatric Center Copenhagen

Gitte MK Knudsen, DMSc

Study Director

Neurobiology Research Unit, Rigshospitalet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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