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

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06098469
• Collaborator: (none)
• Enrollment: 22
• Arm: 1
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression	Device: Neurofeedback sessions	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurofeedback 10 neurofeedback sessions + depressive rating scales	Device: Neurofeedback sessions; 10 Neurofeedback sessions, psychiatric interview (MADRS, QIDS-C16), reverse-correlation task, QIDS-SR16, EQ-5D-5L, motivation assessment

Outcome Measures

Primary Outcome Measures

1. Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

• Principal Investigator: Emmanuel HAFFEN, MD PhD, CHU de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT06098469
• Other Study ID Numbers: API/2019/102
• First Posted: Oct 24, 2023
• Last Update Posted: Oct 24, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Oct 24, 2023