NCT06098469RecruitingNot Applicable
Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
Centre Hospitalier Universitaire de Besancon2 sites in 1 country22 target enrollmentStarted: October 10, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission
Study Overview
Brief Summary
The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects aged 25 to 65 included
- •Information and signed informed consent
- •Patients with a diagnosis of major depressive episode in remission
- •MADRS score between 14 and 22
- •Patients with residual symptoms as assessed by MADRS items
- •No cognitive impairment.
- •Right-handed
Exclusion Criteria
- •Subjects with legal incapacity or limited legal capacity
- •Subjects unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
- •Pregnant women
- •Subjects in the exclusion period of another study or is on the "national volunteer list".
- •Subjects with another psychiatric pathology (bipolar mood disorder, psychosis, obsessive-compulsive disorder, addictive pathology, schizophrenia)
- •Subjects under a protective measure such as guardianship or safeguard of justice.
Arms & Interventions
Neurofeedback
Experimental
10 neurofeedback sessions + depressive rating scales
Intervention: Neurofeedback sessions (Device)
Outcomes
Primary Outcomes
Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission
Time Frame: Week 10
Reduction in MADRS score to \< 8 (complete remission) after 10 neurofeedback sessions, in particular cumulative score less than or equal to 2 for hedonic and fatigue dimensions
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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