Bipolar Disorder DepressionNCT05608135
AI-based Multi-center Research on Identification/Classification/Aided Diagnosis of Mood Disorder
An observational study of Bipolar Disorder Depression and Major Depression, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
At present, diagnosis and recognition of depression and bipolar disorder are mainly based on subjective evidence such as clinical interview and scale evaluation. The corresponding diagnosis basis has some shortcomings, such as poor diagnostic reliability and failure in early identification of bipolar disorder. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder Depression, Major Depression
- How many people
- 960 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to Dec 2025
- Phase
- Observational
- 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study will be conducted primarily at the First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, starting from October 1, 2021, with an estimated total enrollment of 120 participants. Other participating centers include Peking University Sixth Hospital, At the Third Affiliated Hospital of Sun Yat-sen University, At the Second Affiliated Hospital of Kunming Medical University, At Wuhan People's Hospital, At Xiaoshan Hospital in Zhejiang Province, At Wenzhou seventh People's Hospital, At Ruian Fifth People's Hospital, respectively an evaluated 120 participants to be recruited.All research centers of the participants are from China. In screening interviews, the above criteria were carefully examined by two independent investigators.
Who may be able to join
- Age 15-55, regardless of gender;
- The brief International Neuropsychiatric Interview Chinese version (MINI) was used to meet the diagnostic criteria for DSM-IV-TR depressive disorder or bipolar disorder (type I);
- Total score of Hamilton Depression Scale (HAMD-17) ≥17, and Young's Manic Scale (YMRS) ≤6;
- Junior high school or above.
Who cannot join
- The patient conforms to DSM-IV schizophrenia and related spectrum disorders.
- The patient has a history of severe head trauma (loss of consciousness for more than 5 minutes), current or previous history of epilepsy, intracranial hypertension, or other serious neurological diseases;
- Had a history of alcohol or psychoactive substance abuse/dependence in the 6 months prior to the test;
- Those considered unsuitable for inclusion by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Hu ShaoHua, 13957162903, dorhushaohua@zju.edu.cn
About this study
Official title: Recognition/Classification/Auxiliary Diagnosis of Affective Disorder Based on AI:A Multi-center Study
At present, diagnosis and recognition of depression and bipolar disorder are mainly based on subjective evidence such as clinical interview and scale evaluation. The corresponding diagnosis basis has some shortcomings, such as poor diagnostic reliability and failure in early identification of bipolar disorder. Therefore, it is of great significance to explore objective diagnostic indicators to remedy the deficiencies.
Therefore，the investigators collect psychological and physiological information data of patients with bipolar disorder and depression.Then the investigators aim to construct and verify the multidimensional emotion recognition model to analyze the personality characteristics, negative emotions and cognitive reactions of different individuals, and form a systematic accurate recognition and evaluation tool.
- Conditions
- Bipolar Disorder Depression, Major Depression
- Keywords
- Bipolar Disorder Depression, Major Depression, Machine Learning, Skin Potential, Micro-Facial Expression, Electroencephalogram
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
facial action unit detection
The research recruits subjects to look at pictures and videos and then use cameras to record facial microexpressions. Finally, the research uses machine learning methods to analyze facial micro-expressions. Facial micro-expressions (MEs) are involuntary movements of the face that occur spontaneously when a person experiences an emotion but attempts to suppress or repress the facial expression, typically found in a high-stakes environment.
Measured: Baseline
event-related potentials
An electroencephalogram (EEG) is a test that measures electrical activity in the brain using small, metal discs (electrodes) attached to the scalp. Brain cells communicate via electrical impulses and are active all the time, even during asleep. This activity shows up as wavy lines on an EEG recording. The research recruits subjects to look at videos and pictures and use electroencephalography to record event-related potentials. Finally, we use time domain analysis and frequency analysis to get the results
Measured: Baseline
Galvanic skin response
The skin also has electrical activity, which is in constant, slight variation, and can be measured and charted. The skin's electrical conductivity fluctuates based on certain bodily conditions, and this fluctuation is called the galvanic skin response.We recruited subjects to watch videos and pictures and record galvanic skin response. Finally, we use time domain analysis and frequency analysis to get the results
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder DepressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608135
- Sponsor's protocol ID
- IIT20210021B-R2
- Status last verified
- Mar 2023
- First submitted
- 28 Sep 2022
- Last updated
- 10 Mar 2023
- 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 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognition/Classification/Auxiliary Diagnosis of Affective Disorder Based on AI:A Multi-center Study
- ClinicalTrials.gov ID
- NCT05608135
- Acronym / sponsor ID
- IIT20210021B-R2
- Conditions
- Bipolar Disorder Depression, Major Depression
- Keywords
- Bipolar Disorder Depression, Major Depression, Machine Learning, Skin Potential, Micro-Facial Expression, Electroencephalogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Nov 2022 (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.
At present, diagnosis and recognition of depression and bipolar disorder are mainly based on subjective evidence such as clinical interview and scale evaluation. The corresponding diagnosis basis has some shortcomings, such as poor diagnostic reliability and failure in early identification of bipolar disorder. Therefore, it is of great significance to explore objective diagnostic indicators to remedy the deficiencies.
Therefore，the investigators collect psychological and physiological information data of patients with bipolar disorder and depression.Then the investigators aim to construct and verify the multidimensional emotion recognition model to analyze the personality characteristics, negative emotions and cognitive reactions of different individuals, and form a systematic accurate recognition and evaluation tool.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will be conducted primarily at the First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, starting from October 1, 2021, with an estimated total enrollment of 120 participants. Other participating centers include Peking University Sixth Hospital, At the Third Affiliated Hospital of Sun Yat-sen University, At the Second Affiliated Hospital of Kunming Medical University, At Wuhan People's Hospital, At Xiaoshan Hospital in Zhejiang Province, At Wenzhou seventh People's Hospital, At Ruian Fifth People's Hospital, respectively an evaluated 120 participants to be recruited.All research centers of the participants are from China. In screening interviews, the above criteria were carefully examined by two independent investigators.
Key inclusion criteria (4 listed)
- Age 15-55, regardless of gender;
- The brief International Neuropsychiatric Interview Chinese version (MINI) was used to meet the diagnostic criteria for DSM-IV-TR depressive disorder or bipolar disorder (type I);
- Total score of Hamilton Depression Scale (HAMD-17) ≥17, and Young's Manic Scale (YMRS) ≤6;
- Junior high school or above.
Key exclusion criteria (4 listed)
- The patient conforms to DSM-IV schizophrenia and related spectrum disorders.
- The patient has a history of severe head trauma (loss of consciousness for more than 5 minutes), current or previous history of epilepsy, intracranial hypertension, or other serious neurological diseases;
- Had a history of alcohol or psychoactive substance abuse/dependence in the 6 months prior to the test;
- Those considered unsuitable for inclusion by the researcher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
facial action unit detection
Time frame: Baseline
The research recruits subjects to look at pictures and videos and then use cameras to record facial microexpressions. Finally, the research uses machine learning methods to analyze facial micro-expressions. Facial micro-expressions (MEs) are involuntary movements of the face that occur spontaneously when a person experiences an emotion but attempts to suppress or repress the facial expression, typically found in a high-stakes environment.
event-related potentials
Time frame: Baseline
An electroencephalogram (EEG) is a test that measures electrical activity in the brain using small, metal discs (electrodes) attached to the scalp. Brain cells communicate via electrical impulses and are active all the time, even during asleep. This activity shows up as wavy lines on an EEG recording. The research recruits subjects to look at videos and pictures and use electroencephalography to record event-related potentials. Finally, we use time domain analysis and frequency analysis to get the results
Galvanic skin response
Time frame: Baseline
The skin also has electrical activity, which is in constant, slight variation, and can be measured and charted. The skin's electrical conductivity fluctuates based on certain bodily conditions, and this fluctuation is called the galvanic skin response.We recruited subjects to watch videos and pictures and record galvanic skin response. Finally, we use time domain analysis and frequency analysis to get the results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder Depression and Major Depression, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 4 inclusion and 4 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 10 Mar 2023. 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 China. 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 Hu ShaoHua, M.D (+86 13357169115, dorhushaohua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
facial action unit detection (time frame: Baseline). The study lists 3 primary outcomes in all. 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 10 Mar 2023.