- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793176
Vibraimage Technology for Detecting Depression in Psychiatric Outpatients
March 1, 2025 updated by: Yi Feng, MD, Peking University People's Hospital
Diagnostic Accuracy of Vibraimage Technology for Detecting Depression in a Psychiatric Outpatient Setting
Vibraimage technology captures high-frame-rate images of head-neck movements, converting them into vibraimages that display muscle vibration amplitude and frequency.
Using algorithms and calculations, it derives an emotional index from these images.
This non-contact, objective method analyzes psychological indicators through micro-movement detection.
An algorithm has been developed to detect depression by calculating 12 emotional and 2 psychophysiological parameters.
This diagnostic accuracy study aims to validate the technology's ability to diagnose depression in psychiatric outpatients.
Study Overview
Study Type
Observational
Enrollment (Actual)
601
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100096
- Beijing HuiLongGuan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Psychiatric outpatients attending the Beijing Huilongguan Hospital during the study period.
Description
Inclusion Criteria:
- Aged 18 to 70 years.
- No difficulties in reading or writing Chinese; fluent in Mandarin.
- Currently not taking psychotropic medications or on a stable dose for at least 6 weeks.
- Provided informed consent to participate in the study.
Exclusion Criteria:
- Schizophrenia.
- Bipolar disorder.
- History of organic brain disease or significant head trauma.
- Presence of severe systemic medical conditions.
- Suicidal ideation or a score ≥3 on Item 3 ("Suicide") of the 17-item Hamilton Depression Rating Scale (HAMD-17).
- Substance dependence or abuse.
- Intellectual disability or dementia.
- Inability to complete video capture or cooperate due to uncontrollable factors (e.g., hyperactivity, Parkinson's disease, or other conditions that prevent remaining still)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Depressed Group
This group consists of individuals who were ultimately diagnosed with depression by a specialist physician.
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A 20-second video capture of head-neck movements at high frame rates is conducted for all participants to obtain high-resolution images.
The captured videos are analyzed using an algorithm based on Vibraimage technology to infer whether the participants have depression.
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Non-Depressed Group
This group consists of individuals who were ultimately diagnosed as not having depression by a specialist physician.
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A 20-second video capture of head-neck movements at high frame rates is conducted for all participants to obtain high-resolution images.
The captured videos are analyzed using an algorithm based on Vibraimage technology to infer whether the participants have depression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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discrimination
Time Frame: Participants undergo video capture and same-day clinical diagnosis by a physician. Video analysis and suggestive diagnosis are completed on the following day.
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The primary outcome measure is the diagnostic discrimination of Vibraimage technology for depression, assessed by calculating the area under the receiver operating characteristic (ROC) curve.
Participants first undergo video capture, followed by a clinical diagnosis of depression by a physician.
Both the physician and participants are blinded to the results of the video analysis.
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Participants undergo video capture and same-day clinical diagnosis by a physician. Video analysis and suggestive diagnosis are completed on the following day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2025
Primary Completion (Actual)
March 1, 2025
Study Completion (Actual)
March 1, 2025
Study Registration Dates
First Submitted
January 20, 2025
First Submitted That Met QC Criteria
January 20, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 1, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vibraimage_Psychiatric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data will be made available to qualified researchers upon reasonable request.
Data sharing will be subject to approval by the principal investigator (PI) and the study sponsor.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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