Clinical trial NCT05608135: AI-based Multi-center Research on Identification/Classification/Aided Diagnosis of Mood Disorder
Official title: Recognition/Classification/Auxiliary Diagnosis of Affective Disorder Based on AI:A Multi-center Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bipolar Disorder Depression
Major Depression
Keywords: Bipolar Disorder Depression
Major Depression
Machine Learning
Skin Potential
Micro-Facial Expression
Electroencephalogram
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 960
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age 15-55, regardless of gender;
2. 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);
3. Total score of Hamilton Depression Scale (HAMD-17) ≥17, and Young's Manic Scale (YMRS) ≤6;
4. Junior high school or above.

Exclusion Criteria:

1. The patient conforms to DSM-IV schizophrenia and related spectrum disorders.
2. 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;
3. Had a history of alcohol or psychoactive substance abuse/dependence in the 6 months prior to the test;
4. Those considered unsuitable for inclusion by the researcher.

Primary outcomes:
measure: facial action unit detection
timeFrame: Baseline
measure: event-related potentials
timeFrame: Baseline
measure: Galvanic skin response
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: