Construction of Nutritional Path for Mental Diseases

Construction of Nutritional Optimization Path for Prevention and Treatment of Common Mental Diseases Based on Skin Response Quantification Instrument

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.

Study Overview

• Status: Recruiting
• Conditions: Clinical High-risk
• Intervention / Treatment: Other: routine clinical treatment

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Help-seeking first-visit participants will be consecutively recruited from the Shanghai Psychotherapy and Psychological Counselling Centre at the Shanghai Mental Health Centre. They will be screened for eligibility by their clinicians.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UFACH; Unsaturated Fatty Acid in Clinical High-risk	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to psychosis	It will be determined using the criteria for the Presence of Psychotic Symptoms from SIPS. Specifically, the conversion will be defined by the presence of level 6 positive symptoms (the rating "6" refers to severe and psychotic symptoms) identified as either dangerous, disorganised, or occurring at least one hour a day on average, over four days a week for at least 16 hours.	4 weeks
Poor function	It will be determined by GAF score. Specifically, poor function outcome is defined as the GAF score of less than 60 at the follow-up point.	4 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: nicotinic acid; skin flush reaction
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2020080501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No