Identifying predictors for treatment response in major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pilot test of the bWell‑D VR cognitive program for adults with major depression

  This pilot will test whether a VR cognitive assessment and an eight‑week VR cognitive training program (bWell‑D) are acceptable and doable for adults with major depressive disorder who report cognitive problems.

  Recruiting University of British Columbia · Vancouver, British Columbia · NCT06546917

• Assessing cognitive and quality of life issues in advanced cancer survivors treated with immunotherapy

  This study is testing a new therapy to see if it can help advanced cancer survivors who have received immunotherapy improve their mental health and cognitive challenges.

  Recruiting at 2 sites Universitair Ziekenhuis Brussel · Brussels, Brussels Capital and 1 other locations · NCT05667857

• Long-term outcomes after vacuum-induced tamponade for postpartum hemorrhage

  This study will look at women who had postpartum hemorrhage treated with vacuum-induced tamponade at a Zurich hospital to see how they fared over time, including future pregnancies and fertility.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07885072

• New flutemetamol F18 formulation to see if it works as well as current for brain amyloid imaging

  Researchers are testing a new flutemetamol F18 formulation (GE-287) to see if it identifies brain amyloid as accurately as the current formulation in people 50 and older who are undergoing amyloid PET scans for cognitive decline.

  Recruiting at 5 sites Phase 2 GE Healthcare · Aventura, Florida and 5 other locations · NCT07873463

• Longevity Metrics AI/ML Development Study

  Researchers are testing AI models that score health screening tests and predict outcomes like life expectancy for adults, using ongoing follow-up data.

  Recruiting Longevity Metrics, Inc. · Boulder, Colorado · NCT07808619

• Immersive nature-based wellbeing program for older adults with cognitive impairment

  A nature-inspired immersive virtual reality program is being tested to see if it can improve well-being and daily function for older adults with mild to moderate cognitive impairment.

  Recruiting Consorci Sanitari de Terrassa · Terrassa, Barcelona · NCT07802392

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.