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

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurofeedback sessions
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Neurofeedback

    Arm Description

    10 neurofeedback sessions + depressive rating scales

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06098469
    Brief Title
    Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
    Acronym
    DEEP BLUE
    Official Title
    Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neurofeedback
    Arm Type
    Experimental
    Arm Description
    10 neurofeedback sessions + depressive rating scales
    Intervention Type
    Device
    Intervention Name(s)
    Neurofeedback sessions
    Intervention Description
    10 Neurofeedback sessions, psychiatric interview (MADRS, QIDS-C16), reverse-correlation task, QIDS-SR16, EQ-5D-5L, motivation assessment
    Primary Outcome Measure Information:
    Title
    Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission
    Description
    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
    Time Frame
    Week 10

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karine CHARRIERE, PhD
    Phone
    +333 81218999
    Email
    kcharriere@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emmanuel HAFFEN, MD PhD
    Organizational Affiliation
    CHU de Besançon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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