Construction of Nutritional Path for Mental Diseases

NCT ID: NCT04504058

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-10-01

Brief Summary

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The project will focus on the major technical difficulty of "lack of effective nutritional intervention measures for early risk of common mental diseases in China", and rely on the platform of psychiatric risk identification and treatment specialty of Shanghai Mental Health Center, an authoritative institution in the field of mental health, and focus on the effective application of the domestic independent research and development of the artificial intelligence nicotinic acid skin flushing reaction quantification instrument.

Detailed Description

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Based on the biological data of one of the world's largest cohort of psychiatric patients with early phase and risk, nicotinic acid reaction pictures were introduced as biological information for the first time in nutritional intervention of psychiatric risk prevention and control.

Exploration of machine learning and big data analysis methods, based on the objective quantitative evaluation tool, combined with fingertip blood fat spectrum detection, to construct the optimization scheme and targeted non drug intervention measures of nutritional supplement for common mental diseases.

From the perspective of antioxidant stress and nutritional supplement, a new clinical pathway for the prevention and treatment of mental diseases with artificial intelligence products as screening, early warning and guidance prevention will be established.

Conditions

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Clinical High-risk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UFACH

Unsaturated Fatty Acid in Clinical High-risk

routine clinical treatment

Intervention Type OTHER

Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.

Interventions

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routine clinical treatment

Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* be aged 14 to 45-year-old;
* have had at least 6-years of primary education;
* be drug-naïve;
* be understanding the survey, be willing to enrol in the study and sign the informed consent;
* Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome.

Exclusion Criteria

* Through the Mini-International Neuropsychiatric Interview (MINI), Axis I mental disorders such as schizophrenia, affective disorders, and anxiety spectrum disorders will be excluded;
* Acute or chronic renal failure; liver cirrhosis or active liver diseases;
* Abnormal laboratory tests results judged by the researchers to be clinically significant and considered to affect the efficacy of the test drugs or the safety of the subjects;
* Severe or unstable physical diseases, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose above 12 mmol/L;
* Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the trial;
* Pregnant or lactating women, or women in childbearing age who are positive in urine human chorionic gonadotropin test, or men and women who do not take effective contraceptive measures or plan for pregnancy within 3 months after the initiation of the trial;
* Stroke within the last month;
* Participating in any clinical trial within 30 days before the baseline;
* Other situations judged by the investigators not to be suitable for the clinical trial.
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Tianhong ZHANG

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Mental Health Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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TianHong Zhang, Doctor

Role: CONTACT

13127577024

Facility Contacts

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TianHong Zhang, Doctor

Role: primary

13127577024

Other Identifiers

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2020080501

Identifier Type: -

Identifier Source: org_study_id

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