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

NCT ID: NCT06098469

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neurofeedback

10 neurofeedback sessions + depressive rating scales

Group Type EXPERIMENTAL

Neurofeedback sessions

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurofeedback sessions

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emmanuel HAFFEN, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Besançon

Besançon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karine CHARRIERE, PhD

Role: CONTACT

+333 81218999

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karine Charrière, PhD

Role: primary

+33381218999

Magali Nicolier

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

API/2019/102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

fMRI Study of tES in Major Depression
NCT04031547 COMPLETED EARLY_PHASE1