NCT06417437

Brief Summary

Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is approximately 30 million people. At present, due to the lack of neurobiological markers for screening and diagnosing depression, the identification and diagnosis of MDD are based on the judgment of professional doctors, and the treatment mostly relies on clinical symptoms. In terms of treatment, medication remains the main stream for MDD. Although current methods have certain therapeutic effects, patients still suffer from various side effects and poor cognitive function.In current clinical practice, relying purely on symptomatic diagnosis and treatment is difficult to meet the needs of clinical practice, so there is an urgent need to search for neurobiological markers in depression and develop targeted non-invasive intervention technologies. This study aims to combine advanced brain imaging technology, digital twin-brain models, multi-source information decoding technology, integrated detection and intervention technology. The target is to create two new types of non-invasive BCI systems that can regulate emotions. One is a intervention BCI system for MDD that is suitable for hospital settings with the purpose of precise physical stimulation, and the other one is an ecological BCI system that regulate emotions and intervene with depression which is suitable for both hospital settings and future family environments. This study will collect a comprehensive collection of physiological and biochemical indicators from patients with depression and from healthy control groups, as well as multimodal information such as head surface electroencephalography, MRI, and eye movements under different brain states, to personalize the available BCI information of depression related brain regions, circuits, and networks. The study also tries to explore emotional-interactive games that can intervene with depression and build a game data base that is dedicated to MDD. Other goals include designing and establishing two new types of emotional regulation systems, which are precise external physical stimulation intervention and ecological intervention, constructing a BCI regulation system, and conducting application verification to evaluate the regulation effect.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4 depression

Timeline
15mo left

Started Jul 2023

Typical duration for phase_4 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jul 2023Jul 2027

Study Start

First participant enrolled

July 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

4.1 years

First QC Date

April 23, 2024

Last Update Submit

May 12, 2024

Conditions

DepressionMajor Depressive DisorderBipolar Depression

Outcome Measures

Primary Outcomes (18)

  • EEG power in alpha band between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.

    2 weeks

  • EEG power in beta band between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks.

    2 weeks

  • MRI imaging of DLPFC between the depression patient group and healthy controls.

    Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 2 weeks.

    2 weeks

  • HbO in fNIRS between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks.

    2 weeks

  • Hb in fNIRS between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks.

    2 weeks

  • EEG power in alpha band between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks.

    4 weeks

  • EEG power in beta band between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks.

    4 weeks

  • MRI imaging of DLPFC between the depression patient group and healthy controls.

    Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 4 weeks.

    4 weeks

  • HbO in fNIRS between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks.

    4 weeks

  • Hb in fNIRS between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks.

    4 weeks

  • EEG power in alpha band between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks.

    8 weeks

  • EEG power in beta band between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks.

    8 weeks

  • MRI imaging of DLPFC between the depression patient group and healthy controls.

    Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 8 weeks.

    8 weeks

  • HbO in fNIRS between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks.

    8 weeks

  • Hb in fNIRS between the depression patient group and healthy controls.

    Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks.

    8 weeks

  • The score of HAMD-17 in depression patient group and healthy controls.

    Changes from baseline in the score of HAMD-17 at 2 weeks

    2 weeks

  • The score of HAMD-17 in depression patient group and healthy controls.

    Changes from baseline in depression patient group in the score of HAMD-17 at 4 weeks

    4 weeks

  • The score of HAMD-17 in depression patient group and healthy controls.

    Changes from baseline in depression patient group in the score of HAMD-17 at 8 weeks

    8 weeks

Secondary Outcomes (15)

  • The change in the state of depression in depression patient groups

    2 weeks

  • The change in the state of agitation in depression patient groups

    2 weeks

  • The change in the state of depression in depression patient groups

    4 weeks

  • The change in the state of agitation in depression patient groups

    4 weeks

  • The change in the state of depression in depression patient groups

    8 weeks

  • +10 more secondary outcomes

Study Arms (5)

Medication Group

ACTIVE COMPARATOR

Patients with anhedonia will be using either Bupropion or Voxetine. Patients without anhedonia will be given SSRIs. Frequency and dosage will be guided by psychiatrist. Treatment will last 4 weeks.

Drug: SSRI

Traditional rTMs Group

EXPERIMENTAL

In addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has decided to be dlpfc. Treatment will last 4 weeks.

Drug: SSRIDevice: rTMS

New rTMS Group

EXPERIMENTAL

In addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has not been decided, but rbitofrontal cortex, cerebellum and others are considered. Treatment will last 4 weeks.

Drug: SSRIDevice: rTMS

Neuro-Feedback Group

EXPERIMENTAL

In addition to medication using SSRIs, patients will be also treated with Neuro-Training. The process will be guided under fNIRS and monitored by EGG. Treatment will last 4 weeks.

Drug: SSRIBehavioral: Neuro-Feedback

Game-regulation Group

EXPERIMENTAL

In addition to medication using SSRIs, patients will be also treated with games that can regulate emotions. Details are not yet decided. Treatment will last 4 weeks.

Drug: SSRIBehavioral: Game Regulation

Interventions

SSRIDRUG

Patients are not masked from the types of intervention they receive. Assessment will be done before and after each intervention. Each group is independent from other groups.

Game-regulation GroupMedication GroupNeuro-Feedback GroupNew rTMS GroupTraditional rTMs Group
rTMSDEVICE

Patients will be treated targeting either the traditional brain region or new region.

New rTMS GroupTraditional rTMs Group
Neuro-FeedbackBEHAVIORAL

Patients under 18 years old will first be considered this treatment before other methods.

Neuro-Feedback Group
Game RegulationBEHAVIORAL

Patients will learn how to play several games that can supposedly regulate or affect negative emotions.

Game-regulation Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 12 years old, male or female, right-handed, Han ethnicity
  • Meets the DSM-5 diagnostic criteria for depression, with HAMD-17 scores greater than 17 and YMRS scores less than 6;
  • Primary school education or above, able to understand the research content, willing to participate in this study and sign an informed consent form

You may not qualify if:

  • Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy;
  • Severe abnormalities in heart, liver, and kidney function;
  • Patients with severe physical illnesses;
  • History of substance dependence or abuse (alcohol, cocaine, drugs, etc.);
  • Patients with mental disorders caused by organic diseases, drug or alcohol induced mental disorders, and other mental disorders;
  • Pregnancy or lactation period;
  • Within six months, physical therapy such as MECT and TMS should be used;
  • Implants of vegetative nerve stimulation;
  • Individuals who have implanted electronic or metal instruments (such as pacemakers, defibrillators, stents, orthopedic plates, etc.) and undergo ventriculoperitoneal shunt surgery;
  • Obvious visual and auditory impairment, unable to cooperate in completing neuropsychological and scale assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorBipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersBipolar and Related Disorders

Study Officials

  • Zhenghui Yi, chief physician

    Shanghai Mental Health Center

    STUDY CHAIR

Central Study Contacts

Zhenghui Yi, chief physician

CONTACT

18017311007yizhenghui1971@163.com

Qinyu Lv, chief physician

CONTACT

18616550357lvqinyu_louis@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 16, 2024

Study Start

July 1, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)