Status:
UNKNOWN
Construction of Nutritional Path for Mental Diseases
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Clinical High-risk
Eligibility:
All Genders
14-45 years
Brief Summary
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 psychia...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04504058
Start Date
October 1 2020
End Date
October 1 2021
Last Update
March 24 2021
Active Locations (1)
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1
Shanghai Mental Health Center
Shanghai, China, 200030