DepressionDEEPBLUENCT06098469
Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
A study testing Neurofeedback sessions in people with Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Neurofeedback sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
Karine Charrière, PhD, +33381218999, kcharriere@chu-besancon.fr
Magali Nicolier, mnicolier@chu-besancon.fr
About this study
The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.
- Conditions
- Depression
- Being tested
- Neurofeedback sessions
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback sessionsDevice
10 Neurofeedback sessions, psychiatric interview (MADRS, QIDS-C16), reverse-correlation task, QIDS-SR16, EQ-5D-5L, motivation assessment
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | 10 neurofeedback sessions + depressive rating scales Receives: Device: Neurofeedback sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start10 Oct 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel HAFFEN, MD PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098469
- Sponsor's protocol ID
- API/2019/102
- Acronym
- DEEPBLUE
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
- ClinicalTrials.gov ID
- NCT06098469
- Acronym / sponsor ID
- DEEPBLUE / API/2019/102
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: Neurofeedback sessions10 neurofeedback sessions + depressive rating scales |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback sessions10 Neurofeedback sessions, psychiatric interview (MADRS, QIDS-C16), reverse-correlation task, QIDS-SR16, EQ-5D-5L, motivation assessment | Device | Neurofeedback |
Primary outcome
Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel HAFFEN, MD PhD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback sessions in people with Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karine CHARRIERE, PhD (+333 81218999, kcharriere@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.