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NCT06098469 Clinical Trial

Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression

Depression Clinical Trial

— DEEPBLUE  

Official title:
Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06098469
Other study ID # API/2019/102
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date February 2025

Study information
Verified date March 2024
Source Centre Hospitalier Universitaire de Besancon
Contact Karine CHARRIERE, PhD
Phone +333 81218999
Email kcharriere@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 22
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Neurofeedback sessions
10 Neurofeedback sessions, psychiatric interview (MADRS, QIDS-C16), reverse-correlation task, QIDS-SR16, EQ-5D-5L, motivation assessment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission 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 Week 10
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