Clinical High-riskNCT04504058
Construction of Nutritional Path for Mental Diseases
An observational study of Clinical High-risk, run by Shanghai Mental Health Center at 1 site in China.
Trial 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 psychiatric risk identification and treatment specialty of Shanghai Mental Health Center, an authoritative institution in the… Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Clinical High-risk
- What is being tested?
- routine clinical treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Oct 2021
- 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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, 200030
TianHong Zhang, Doctor, 13127577024, zhang_tianhong@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Clinical High-risk
- Being tested
- routine clinical treatment
- Keywords
- nicotinic acid; skin flush reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine clinical treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| UFACH | Unsaturated Fatty Acid in Clinical High-risk Receives: Other: routine clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High-riskStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianhong ZHANG, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504058
- Sponsor's protocol ID
- 2020080501
- Status last verified
- Mar 2021
- First submitted
- 5 Aug 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Nutritional Optimization Path for Prevention and Treatment of Common Mental Diseases Based on Skin Response Quantification Instrument
- ClinicalTrials.gov ID
- NCT04504058
- Acronym / sponsor ID
- 2020080501
- Conditions
- Clinical High-risk
- Keywords
- nicotinic acid; skin flush reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 7 Aug 2020 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UFACH | – | Other: routine clinical treatmentUnsaturated Fatty Acid in Clinical High-risk |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine clinical treatmentParticipants 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. | Other | UFACH |
Primary outcome
Conversion to psychosis
Time frame: 4 weeks
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.
Poor function
Time frame: 4 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: Yes
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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 Clinical High-risk, run by Shanghai Mental Health Center 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 5 inclusion and 9 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 24 Mar 2021. 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 TianHong Zhang, Doctor (13127577024, zhang_tianhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to psychosis (time frame: 4 weeks). The study lists 2 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 24 Mar 2021.