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FMRI-neurofeedback in Depression

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Dec 31, 2026 → Apr 30, 2027
See other at-risk trials from Maastricht University Medical Center

Record History

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  1. Primary completion pushed from Dec 31, 2026 to Apr 30, 2027 Show 4 more changesShow less
    • Study completion pushed from Apr 30, 2027 to Jul 31, 2027
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 12 of 12 entries
    • Study description revised
  2. Lead sponsor: Maastricht University to Maastricht University Medical Center
    • Primary completion date: Apr 30, 2024 to Dec 31, 2026
    • Study completion date: Apr 30, 2024 to Apr 30, 2027
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2022 to Jan 25, 2023
    • Secondary endpoints: details revised at 6 of 12 entries
    • Study description shortened, about 30 words
    • Site details revised at 3 of 3 sites
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05640089
Lead Sponsor Maastricht University Medical Center
Conditions
(from sponsor)		 Depression, Unipolar
Related terms Behavioral Symptoms, Depression, Depressive Disorder, Mental Disorders, Mood Disorders
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov