NCT06098469

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 26, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

October 19, 2023

Last Update Submit

November 22, 2024

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Neurofeedback

EXPERIMENTAL

10 neurofeedback sessions + depressive rating scales

Device: Neurofeedback sessions

Interventions

Neurofeedback sessionsDEVICE

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

Neurofeedback

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Emmanuel HAFFEN, MD PhD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine CHARRIERE, PhD

CONTACT

+333 81218999kcharriere@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 24, 2023

Study Start

October 10, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

November 26, 2024

Record last verified: 2024-03

Locations

FR(1)