Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Denmark / NCT05616559
Recruiting Observational

Precision Medicine in the Depression Treatment

NCT05616559 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Observational
Started
2021-06-15
Last updated
2024-10-08

Condition(s) studied

Depressive Disorder, MajorTreatment OutcomeCognitive DysfunctionCognitive Behavioral TherapyAntidepressive Agents

Investigational drug(s) / intervention(s)

Treatment Package for First-Episode Depression

Treatment Package for First-Episode Depression: The outpatient 'treatment package' for first episode depression is a national uniform package designed by Mental Health Services in the Capital Region. The treatment package for first-episode depression is a program with manualized group CBT, psychoeducation of patients and relatives, and relapse prevention. Antidepressant medication and individual psychotherapy are available as needed.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinical remission — Baseline to 6 months after treatment start
    Quick Inventory of Depressive Symptomatology (QIDS) score of ≤5
  • Clinical improvement — Baseline to 6 months after treatment start
    ≥50% reduction in QIDS score.

Trial sites (1)

FacilityCityRegionStatus
Neurobiology Research Unit, Rigshospitalet Copenhagen Denmark Recruiting

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

Effect of Large Neutral Amino Acids in Adults With Classical Phenylketonuria Recruiting
Immediate Versus Postponed Single Blastocyst Transfer in mNC-FET Active, not recruiting
The Copenhagen Gender Identity Cohort Recruiting
Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection Recruiting
Postoperative Exercise Training and Colorectal Cancer Liver Metastasis Active, not recruiting

Other trials for the same condition

Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study Recruiting
COMPuter-assisted Self-training to Improve EXecutive Function Active, not recruiting
Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05616559 on ClinicalTrials.gov ↗ ← All trials in Denmark