Trial Information
Current as of January 17, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for people with depression. Researchers want to see if combining a special brain training technique called fMRI-neurofeedback with standard care can help reduce symptoms of depression more effectively than just standard care alone. During the study, participants will either receive regular treatment for depression or regular treatment plus five sessions of fMRI-neurofeedback training, which helps them learn to control certain brain activities. The severity of their depression will be measured before the treatment, right after, and again six months later.
To participate in this trial, individuals must have a diagnosis of depression and have been on stable antidepressant medication for at least four weeks. They should currently be experiencing moderate to severe depression. However, some people may not be eligible, such as those with certain medical devices or a history of severe mental health issues. If you or someone you know is interested, it’s important to talk to a healthcare provider to see if they qualify and to learn more about what to expect during the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of a depressive disorder (ICD-10: F32 or F33)
- • Has been on stable antidepressant medication (single or combination treatment) for at least 4 weeks
- • Current depression (QIDS \>= 17)
- • If required to meet recruitment targets the minimum entry score will be reduced QIDS \>= 13 (i.e. still corresponding to a moderate level of depression)
- Exclusion Criteria:
- • Exclusion criteria for MRI (e.g. cardiac pacemaker, certain metallic implants)
- • History of psychotic disorder bipolar disorder, or psychotic depression
- • Current use of illegal drugs (any in the last four weeks)
- • Current excessive alcohol consumption that interferes with daily functioning
- • History of neurological disease that could influence the fMRI signal and/or the anatomical alignment (e.g. territorial stroke, multiple sclerosis, brain tumour)
Trial Officials
David E Linden, Prof.
Principal Investigator
Professor of Translational Neuroscience
About Maastricht University
Maastricht University is a leading academic institution in the Netherlands, renowned for its innovative approach to research and education in the health sciences. With a strong emphasis on interdisciplinary collaboration, the university actively engages in clinical trials that aim to advance medical knowledge and improve patient outcomes. Maastricht University leverages its state-of-the-art facilities and expertise in various fields, including biomedical research, public health, and clinical practice, to conduct high-quality clinical studies that adhere to rigorous ethical standards. Committed to translating research findings into real-world applications, the university plays a pivotal role in addressing contemporary health challenges and enhancing healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Maastricht, , Netherlands
Maastricht, , Netherlands
Maastricht, , Netherlands
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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