NCT04685083

Brief Summary

This study aims to collect the voice output of depression patients and healthy subjects, extract the acoustic and semantic parameters, compare the similarities and differences between the depression group and the healthy control group horizontally, and track the depression patients' changes in the rehabilitation stage to construct a voice-based early warning model of depression recurrence. At the same time, the use of EEG technology, nuclear magnetic resonance and near-infrared brain imaging technology to record and analyze the neural activity characteristics behind the voice variation of depression patients, and build a neural mechanism model. And construct the facial recognition function through the convolutional neural network, extract the facial parameters to enrich the intelligent monitoring and early warning technology.

  1. 1.Collect linguistic data of depression patients and healthy people collected in the laboratory, as well as data related to changes in the condition of depression patients in daily life and home care after treatment, and construct comparative data and dynamic observations Large database to analyze its voice mutation characteristics;
  2. 2.Using EEG technology, nuclear magnetic resonance, and near-infrared brain imaging to record and analyze the neural activity characteristics behind the voice variation of depression patients, and build a neural mechanism model.
  3. 3.Use the convolutional neural network to realize the facial recognition function, and extract the facial parameters to enrich the monitoring indicators.
  4. 4.Based on the dynamic observation big data of depression speech mutation, construct the speech feature parameter vector of depression recurrence, and use adaptive personalized intelligent learning algorithm to develop intelligent monitoring and early warning technology.
  5. 5.Establish monitoring and diagnostic indicators for recurrence early warning, verify the application of the above-mentioned intelligent monitoring and early warning technology in rehabilitation guidance, and make a comprehensive assessment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 18, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

December 31, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 19, 2021

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 18, 2020

Last Update Submit

May 17, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Acoustic parameters

    Acoustic parameters of depression patients and healthy subjects are extracted through voice recording.

    2022.6

  • Neural activity parameters of EEG

    Neural activity parameters of depression patients and healthy subjects are extracted through EEG technology.

    2022.6

  • Neural activity parameters of MRI

    Neural activity parameters of depression patients and healthy subjects are extracted through MRI.

    2022.6

  • Neural activity parameters of near-infrared brain imaging

    Neural activity parameters of depression patients and healthy subjects are extracted through near-infrared brain imaging.

    2022.6

  • Facial action parameters of facial expression recognition technology

    The facial expression recognition technology is implemented by convolutional neural network to extract facial action parameters.

    2022.6

Study Arms (3)

Patients with Depression in consolidation phase

Patients with Depression in acute onset

Healthy subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is planned to collect 80 patients with depression in the consolidating stage, 80 patients with depression in the acute stage, and 80 healthy controls recruited by advertisement in the psychological consultation clinic and psychiatric clinic of Shanghai Mental Health Center.

You may qualify if:

  • Patients with depression in the consolidation/maintenance phase
  • years old, no gender limit;
  • Meet the DSM-5 diagnostic criteria for depression;
  • Currently in the consolidation/maintenance phase, with stable condition, HAMD-17 \<7 points;
  • Patients and their guardians understand the nature of this study and sign an informed consent form.
  • Have sufficient audiovisual level to complete the necessary inspections for research;
  • Han nationality
  • Willing to participate in this research;
  • Education level is junior high school and above.
  • Patients with depression in acute onset:
  • years old, no gender limit;
  • Meet the DSM-5 diagnostic criteria for depression;
  • Currently in depressive episode, HAMD-17\>17 points;
  • Patients and their guardians understand the nature of this study and sign an informed consent form.
  • Have sufficient audiovisual level to complete the necessary inspections for research;
  • +10 more criteria

You may not qualify if:

  • Patients with depression in the consolidation/maintenance phase
  • Patients with severe brain diseases and other severe physical diseases;
  • Diagnosis of other mental diseases such as schizophrenia and bipolar disorder;
  • There are negative beliefs or a higher risk of suicide;
  • People who are addicted to psychoactive substances such as alcohol or drugs;
  • Women who are pregnant or about to become pregnant recently, and women who are breastfeeding;
  • There are metal implants in the body: there is a pacemaker, intracranial silver clip, metal denture, arterial stent, arterial clip, joint metal fixation, or other metal implant conditions, or non-right-handed (this standard (Only for MRI testers);
  • Failure to sign or refuse to sign the informed consent form.
  • Patients with depression in acute onset:
  • Patients with severe brain diseases and other severe physical diseases;
  • Diagnosis of other mental diseases such as schizophrenia and bipolar disorder;
  • There are negative beliefs or a higher risk of suicide;
  • People who are addicted to psychoactive substances such as alcohol or drugs;
  • Women who are pregnant or about to become pregnant recently, and women who are breastfeeding;
  • There are metal implants in the body: there is a pacemaker, intracranial silver clip, metal denture, arterial stent, arterial clip, joint metal fixation, or other metal implant conditions, or non-right-handed (this standard (Only for MRI testers);
  • +9 more criteria

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

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

December 28, 2020

Study Start

December 31, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

May 19, 2021

Record last verified: 2020-11

Locations