| NCT ID | NCT05640089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Depression, Unipolar |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-01-25 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction. The goal of this clinical trial is to compare fMRI-neurofeedback plus standard care with standard care in patients with depression. Participants will either receive standard care, or standard care plus a fMRI neurofeedback training, consisting of 5 neurofeedback training sessions. Symptom severity will be assessed before, immediately after and 6 months after the intervention.
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)
Contact & Investigator
David E Linden, Prof.
PRINCIPAL INVESTIGATOR
Professor of Translational Neuroscience
Frequently Asked Questions
Who can join the NCT05640089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression, Unipolar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05640089 currently recruiting?
Yes, NCT05640089 is actively recruiting participants. Contact the research team at david.linden@maastrichtuniversity.nl for enrollment information.
Where is the NCT05640089 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Maastricht, Netherlands, Maastricht, Netherlands.
Who is sponsoring the NCT05640089 clinical trial?
NCT05640089 is sponsored by Maastricht University Medical Center. The principal investigator is David E Linden, Prof. at Professor of Translational Neuroscience. The trial plans to enroll 120 participants.
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