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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

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