SchizophreniaNCT03451734
Optimizing and Individualizing the Pharmacological Treatment of First-episode Schizophrenic Patients
An observational study of Schizophrenia and Metabolic Syndrome, run by Central South University at 1 site in China.
Trial summary
The study is performed in 20 different hospitals from 19 cities in China. Three sub-projects are included. About sub-project 1, we build a clinical database system and a biological sample bank for data and samples management, which is applicable in other hospitals in this project. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome
- What is being tested?
- antipsychotic medications, adjunctive group and metformin and lifestyle intervention
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2018to 30 Jun 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 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia;Duration of illness less than 3 years with current symptoms exacerbation;Male and female with aged 17 to 65 years;
Who may be able to join
- Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia;
- Duration of illness less than 3 years with current symptoms exacerbation;
- Male and female with aged 17 to 65 years;
- Signed the study consent for participation
Who cannot join
- Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
- Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
- Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
- Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
- The routine blood tests showing abnormal renal, liver function;
- Pregnant or lactating women.
- No administration of any antibiotics in a mouth
Trial locations and contacts
1 site in 1 country.
China1 site
Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, Hunan, 410011
About this study
The study is performed in 20 different hospitals from 19 cities in China. Three sub-projects are included. About sub-project 1, we build a clinical database system and a biological sample bank for data and samples management, which is applicable in other hospitals in this project. 1800 first-episode schizophrenia patients will be recruited in 19 sites and randomized into 6 treatment groups (olanzapine, risperidone, aripiprazole, ziprasidone, amisulpride, haloperidol). Through 8-week treatment and follow-up, we collect multidimensional indexes from psychopathology, neuropsychology, brain imaging, physiology, biochemistry, and life stress data. The summarized data is analyzed to screen potential biomarkers or biomarker panel that may predict the antipsychotic response, and ultimately to establish a prediction model.Sub-project 2, as an extension of sub-project 1, includes verification of the prediction model established in sub-project 1 and optimization of the current therapy with add-on treatment. Firstly, the validation process of the prediction model undergoes with an independent patient cohort. Next, we apply the add-on treatment to the patients who don't have ideal response to antipsychotic treatment after 8-week treatment. According to the results above, we manage to construct an optimized and individualized therapy for schizophrenia.In the end,We tend to conduct a randomized double-blind controlled trial to assess the safety and efficacy of the combination strategy for antipsychotic-induced metabolism syndrome, which includes metformin and lifestyle intervention. In the meanwhile, for schizophrenia patients at high-risk of metabolic syndrome, we tend to establish a prevention strategy expected to reduce or delay the occurrence of metabolic syndrome, which includes low-dose metformin and lifestyle intervention. We hope to successfully construct a comprehensive intervention strategy on metabolic syndrome induced by antipsychotic medications.
Read the detailed description
For sub-project1 and 2:Inclusion criteria: Participants are ineligible to enter the trial under the following conditions: 1) Participants must be aged 18 to 65 years old who meet the criteria for schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) or International Classification of Diseases- tenth edition (ICD-10); 2) participants are in current episode of psychotic symptoms with a disease course less than 3 years and intermission less than 6 months; 3). there is at least 1 guardian to accompany patient within 1 year; 4). Participants and their guardians must sign an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria (any potential paticipant who meets any of the following criteria will be excluded from participating in the study): 1). Participants with known or suspected clinically unstable systemic medical disorder; 2). participant has a current or prior DSM-5/ ICD-10 diagnosis of substance use disorder, intellectual disability, autism spectrum disorder, dementia or severe cognitive impairment; 3). planning to be pregnant, pregnancy or breast-feeding; 4). currently enrolled in another clinical trial.
For sub-project 3:The diagnostic criteria for Paticipants who develop metabolic syndrome: A. body mass index ≥ 25.0kg / m2; B. hyperglycemia: fasting blood glucose ≥ 110mg/dl (6.1mmol/l) and / or plasma glucose ≥ 140mg/dl(7.8mmol/l) after glucose load; and / or those who have been diagnosed with diabetes and received treatment; C. hypertension: systolic blood pressure (SBP) / diastolic blood pressure (DBP) ≥ 140/90mmHg, and / or those who have been diagnosed as hypertension and received treatment; D. dyslipidemia: at fasting state, total cholesterol (TG) ≥ 150 mg/dl (1.7mmol/l); and / or HDL-C: male < 35mg/dl (0.9mmol/l), female < 39mg/dl (1.0mmol/l) . The inclusive criteria for patients at high-risk of MetS: A. paticipants are taking antipsychotic drugs that significantly affect metabolisms, such as olanzapine, clozapine or risperidone; B. paticipants have family history of diabetes, hypertension and heart disease; C. the age of paticipants is over 40 years old; D. paticipants have no nonalcoholic fatty liver and gout; E. paticipants who have one or two components of metabolic syndrome but do not meet the diagnostic criteria.
For clinical and biological data collection, we collect blood samples and case information, which contains demographic data, medical history (including current medical history, past history, personal history and family history), medication regimen and results of follow-up evaluation. The biological samples are stored using unique code whose storage information can be linked to research case in the web server.
The Standard Operations Procedures (SOPs) are followed for data collection, storage, tracking, and utilization.
Professional technicians are employed for the establishment and subsequent maintenance of Internet platform, including web server and mobile terminal applications (APP). Ancillary researchers are involved for collection and timely upload of case information online. Principal investigators are responsible for auditing the data and quality control.
- Conditions
- Schizophrenia, Metabolic Syndrome
- Being tested
- antipsychotic medications, adjunctive group, metformin and lifestyle intervention
- Keywords
- Optimized and individualized antipsychotic treatment, Side Effect, Efficacy, Biomarker
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antipsychotic medicationsDrug
olanzapine, risperidone, aripiprazole, amisulpride, ziprasidone, and haloperidol groups
adjunctive groupDrug
antipsychotic plus placebo, antipsychotic plus sulforaphane(3 tables per day, consisting of 30 mg of SFN-glucosinolate per day), and antipsychotic plus minocycline(200mg per day) groups.
metformin and lifestyle interventionDrug
different dose metformin combines lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| treatment cohort | in sub-project 1, participants are randomized into olanzapine, risperidone, aripiprazole, amisulpride, ziprasidone, and haloperidol groups, we give them evaluation, and adjust dose of medication and deal with side effect if necessary. Receives: Drug: antipsychotic medications | |
| adjunctive group | Patients who do not have an ideal response to antipsychotics treatment (reduction rate of Positive and Negative Symptom Scale (PANSS) score less than 25%) in sub-project 2 are recruited in this trial. They are randomly assigned to antipsychotic plus placebo, antipsychotic plus sulforaphane(3 tables per day, consisting of 30 mg of SFN-glucosinolate per day), and antipsychotic plus minocycline(200mg per day) groups, and the antipsychotic drugs used at this stage are still consistent with the first trial of sub-project 2. At baseline, 4 weeks and 8 weeks after treatment, all participants receive evaluations. Receives: Drug: adjunctive group | |
| metformin and lifestyle intervention for MetS | Participants who develop MetS at the last visit in sub-project 1 and sub-project 2 are recruited in this trial. Patients are randomized into low-dose metformin (1000 mg/d), high-dose metformin (1500 mg/d), low dose metformin plus lifestyle intervention group (1000 mg/d), high dose metformin plus lifestyle intervention (1500 mg/d), lifestyle intervention, and placebo groups. The timepoints of the visits are at baseline, the 4th week, the 8th week, and the 12th week. Receives: Drug: metformin and lifestyle intervention | |
| metformin and lifestyle prevention for high risk of MetS | Participants who are at a high risk of MetS are recruited in this trial. Participants are randomized into low dose metformin (750 mg/d), high dose metformin (1000 mg/d), lifestyle intervention, and placebo groups. The timepoints of the visits are at baseline, the 4th week, the 8th week, and the 12th week. Receives: Drug: metformin and lifestyle intervention | |
| validation cohort | in sub-project 2, there are1,800 first-episode schizophrenia patients recruited from 19 hospitals, and six groups as with sub-project 1. The assessments (timepoint and content) are conducted as in sub-project 1. Receives: Drug: antipsychotic medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive And Negative Syndrome Scale (PANSS)
The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point.
Measured: 8 weeks
Clinical Global Impressions(CGI)
The change of Clinical Global Impressions(CGI):severity of illness(SI), global improvement(GI) and efficacy index(EI) before and after treatment at different follow up point.
Measured: 8 weeks
Global Assessment Function(GAF)
The change of Global Assessment Function(GAF) before and after treatment at different follow up point.
Measured: 8 weeks
MATRICS Consensus Cognitive Battery (MCCB) composite score
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure before and after treatment at different follow up point.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start23 Jan 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Shanghai Mental Health Center, West China Hospital, First Affiliated Hospital of Zhejiang University, Air Force Military Medical University, China, Jiangsu Province Nanjing Brain Hospital, First Affiliated Hospital of Harbin Medical University, Shanxi Medical University, First Affiliated Hospital of Kunming Medical University, Guangzhou Mental Hospital, First Affiliated Hospital of Chongqing Medical University, Capital Medical University, China Medical University, China, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital Xi'an Jiaotong University, Hebei Medical University, Shenzhen Mental Health Center, Sun Yat-sen University, Wuhan Mental Health Centre, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Renrong Wu,PhD, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451734
- Sponsor's protocol ID
- 2016YFC1306900
- Status last verified
- Aug 2021
- First submitted
- 23 Jan 2018
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu Y, Yang Y, Wu R, Cao D, Jiang F. Association between baseline cognition and clinical response in first-episode schizophrenia. BMC Psychiatry. 2026 Aug 5;26(1):855. doi: 10.1186/s12888-026-08481-4.
PubMed 42972312Gao S, Xu Q, Han Y, Jiang J, Wu F, Peng T, Ling C, Ni S, Zhang R, Ming Y, Liu X, Xu X. Relationship between cognitive impairments and psychopathological symptoms in female schizophrenia subsequent to 8 weeks treatment with antipsychotic drugs. BMC Psychiatry. 2025 Mar 7;25(1):211. doi: 10.1186/s12888-025-06605-w.
PubMed 40055632Xie P, Shao T, Long Y, Xie W, Liu Y, Yang Y, Huang Y, Wu R, Deng Q, Tang H. Orlistat for the treatment of antipsychotic-induced weight gain: an eight-week multicenter, randomized, placebo-controlled, double-blind trial. Lipids Health Dis. 2024 Jul 24;23(1):225. doi: 10.1186/s12944-024-02214-w.
PubMed 39049073Zeng J, Zhang W, Lu X, Zhou H, Huang J, Xu Z, Liao H, Liang J, Liang M, Ye C, Sun T, Hu Y, She Q, Chen H, Guo Q, Yan L, Wu R, Li Z. The association of SOD and HsCRP with the efficacy of sulforaphane in schizophrenia patients with residual negative symptoms. Eur Arch Psychiatry Clin Neurosci. 2024 Aug;274(5):1083-1092. doi: 10.1007/s00406-023-01679-7. Epub 2023 Sep 20.
PubMed 37728803Long Y, Wu Q, Yang Y, Cai J, Xiao J, Liu Z, Xu Y, Chen Y, Huang M, Zhang R, Xu X, Hu J, Liu Z, Liu F, Zheng Y, Meng H, Wang Z, Tang Y, Song X, Chen Y, Wang X, Liu T, Wu X, Fang M, Wan C, Zhao J, Wu R. Early non-response as a predictor of later non-response to antipsychotics in schizophrenia: a randomized trial. BMC Med. 2023 Jul 19;21(1):263. doi: 10.1186/s12916-023-02968-7.
PubMed 37468932Xiao J, Huang J, Long Y, Wang X, Wang Y, Yang Y, Hei G, Sun M, Zhao J, Li L, Shao T, Wang W, Kang D, Liu C, Xie P, Huang Y, Wu R, Zhao J. Optimizing and Individualizing the Pharmacological Treatment of First-Episode Schizophrenic Patients: Study Protocol for a Multicenter Clinical Trial. Front Psychiatry. 2021 Feb 25;12:611070. doi: 10.3389/fpsyt.2021.611070. eCollection 2021.
PubMed 33716817Peng XJ, Hei GR, Li RR, Yang Y, Liu CC, Xiao JM, Long YJ, Shao P, Huang J, Zhao JP, Wu RR. The Association Between Metabolic Disturbance and Cognitive Impairments in Early-Stage Schizophrenia. Front Hum Neurosci. 2021 Feb 22;14:599720. doi: 10.3389/fnhum.2020.599720. eCollection 2020.
PubMed 33692676Huang J, Hei GR, Yang Y, Liu CC, Xiao JM, Long YJ, Peng XJ, Yang Y, Zhao JP, Wu RR. Increased Appetite Plays a Key Role in Olanzapine-Induced Weight Gain in First-Episode Schizophrenia Patients. Front Pharmacol. 2020 May 22;11:739. doi: 10.3389/fphar.2020.00739. eCollection 2020.
PubMed 32528286
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing and Individualizing the Pharmacological Treatment of First-episode Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT03451734
- Acronym / sponsor ID
- 2016YFC1306900
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- Optimized and individualized antipsychotic treatment, Side Effect, Efficacy, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Shanghai Mental Health Center, West China Hospital, First Affiliated Hospital of Zhejiang University, Air Force Military Medical University, China, Jiangsu Province Nanjing Brain Hospital, First Affiliated Hospital of Harbin Medical University, Shanxi Medical University, First Affiliated Hospital of Kunming Medical University, Guangzhou Mental Hospital, First Affiliated Hospital of Chongqing Medical University, Capital Medical University, China Medical University, China, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital Xi'an Jiaotong University, Hebei Medical University, Shenzhen Mental Health Center, Sun Yat-sen University, Wuhan Mental Health Centre, Shanghai Jiao Tong University School of Medicine
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 2 Mar 2018 (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 study is performed in 20 different hospitals from 19 cities in China. Three sub-projects are included. About sub-project 1, we build a clinical database system and a biological sample bank for data and samples management, which is applicable in other hospitals in this project. 1800 first-episode schizophrenia patients will be recruited in 19 sites and randomized into 6 treatment groups (olanzapine, risperidone, aripiprazole, ziprasidone, amisulpride, haloperidol). Through 8-week treatment and follow-up, we collect multidimensional indexes from psychopathology, neuropsychology, brain imaging, physiology, biochemistry, and life stress data. The summarized data is analyzed to screen potential biomarkers or biomarker panel that may predict the antipsychotic response, and ultimately to establish a prediction model.Sub-project 2, as an extension of sub-project 1, includes verification of the prediction model established in sub-project 1 and optimization of the current therapy with add-on treatment. Firstly, the validation process of the prediction model undergoes with an independent patient cohort. Next, we apply the add-on treatment to the patients who don't have ideal response to antipsychotic treatment after 8-week treatment. According to the results above, we manage to construct an optimized and individualized therapy for schizophrenia.In the end,We tend to conduct a randomized double-blind controlled trial to assess the safety and efficacy of the combination strategy for antipsychotic-induced metabolism syndrome, which includes metformin and lifestyle intervention. In the meanwhile, for schizophrenia patients at high-risk of metabolic syndrome, we tend to establish a prevention strategy expected to reduce or delay the occurrence of metabolic syndrome, which includes low-dose metformin and lifestyle intervention. We hope to successfully construct a comprehensive intervention strategy on metabolic syndrome induced by antipsychotic medications.
Detailed description
For sub-project1 and 2:Inclusion criteria: Participants are ineligible to enter the trial under the following conditions: 1) Participants must be aged 18 to 65 years old who meet the criteria for schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) or International Classification of Diseases- tenth edition (ICD-10); 2) participants are in current episode of psychotic symptoms with a disease course less than 3 years and intermission less than 6 months; 3). there is at least 1 guardian to accompany patient within 1 year; 4). Participants and their guardians must sign an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria (any potential paticipant who meets any of the following criteria will be excluded from participating in the study): 1). Participants with known or suspected clinically unstable systemic medical disorder; 2). participant has a current or prior DSM-5/ ICD-10 diagnosis of substance use disorder, intellectual disability, autism spectrum disorder, dementia or severe cognitive impairment; 3). planning to be pregnant, pregnancy or breast-feeding; 4). currently enrolled in another clinical trial.
For sub-project 3:The diagnostic criteria for Paticipants who develop metabolic syndrome: A. body mass index ≥ 25.0kg / m2; B. hyperglycemia: fasting blood glucose ≥ 110mg/dl (6.1mmol/l) and / or plasma glucose ≥ 140mg/dl(7.8mmol/l) after glucose load; and / or those who have been diagnosed with diabetes and received treatment; C. hypertension: systolic blood pressure (SBP) / diastolic blood pressure (DBP) ≥ 140/90mmHg, and / or those who have been diagnosed as hypertension and received treatment; D. dyslipidemia: at fasting state, total cholesterol (TG) ≥ 150 mg/dl (1.7mmol/l); and / or HDL-C: male < 35mg/dl (0.9mmol/l), female < 39mg/dl (1.0mmol/l) . The inclusive criteria for patients at high-risk of MetS: A. paticipants are taking antipsychotic drugs that significantly affect metabolisms, such as olanzapine, clozapine or risperidone; B. paticipants have family history of diabetes, hypertension and heart disease; C. the age of paticipants is over 40 years old; D. paticipants have no nonalcoholic fatty liver and gout; E. paticipants who have one or two components of metabolic syndrome but do not meet the diagnostic criteria.
For clinical and biological data collection, we collect blood samples and case information, which contains demographic data, medical history (including current medical history, past history, personal history and family history), medication regimen and results of follow-up evaluation. The biological samples are stored using unique code whose storage information can be linked to research case in the web server.
The Standard Operations Procedures (SOPs) are followed for data collection, storage, tracking, and utilization.
Professional technicians are employed for the establishment and subsequent maintenance of Internet platform, including web server and mobile terminal applications (APP). Ancillary researchers are involved for collection and timely upload of case information online. Principal investigators are responsible for auditing the data and quality control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| treatment cohort | – | Drug: antipsychotic medicationsin sub-project 1, participants are randomized into olanzapine, risperidone, aripiprazole, amisulpride, ziprasidone, and haloperidol groups, we give them evaluation, and adjust dose of medication and deal with side effect if necessary. |
| adjunctive group | – | Drug: adjunctive groupPatients who do not have an ideal response to antipsychotics treatment (reduction rate of Positive and Negative Symptom Scale (PANSS) score less than 25%) in sub-project 2 are recruited in this trial. They are randomly assigned to antipsychotic plus placebo, antipsychotic plus sulforaphane(3 tables per day, consisting of 30 mg of SFN-glucosinolate per day), and antipsychotic plus minocycline(200mg per day) groups, and the antipsychotic drugs used at this stage are still consistent with the first trial of sub-project 2. At baseline, 4 weeks and 8 weeks after treatment, all participants receive evaluations. |
| metformin and lifestyle intervention for MetS | – | Drug: metformin and lifestyle interventionParticipants who develop MetS at the last visit in sub-project 1 and sub-project 2 are recruited in this trial. Patients are randomized into low-dose metformin (1000 mg/d), high-dose metformin (1500 mg/d), low dose metformin plus lifestyle intervention group (1000 mg/d), high dose metformin plus lifestyle intervention (1500 mg/d), lifestyle intervention, and placebo groups. The timepoints of the visits are at baseline, the 4th week, the 8th week, and the 12th week. |
| metformin and lifestyle prevention for high risk of MetS | – | Drug: metformin and lifestyle interventionParticipants who are at a high risk of MetS are recruited in this trial. Participants are randomized into low dose metformin (750 mg/d), high dose metformin (1000 mg/d), lifestyle intervention, and placebo groups. The timepoints of the visits are at baseline, the 4th week, the 8th week, and the 12th week. |
| validation cohort | – | Drug: antipsychotic medicationsin sub-project 2, there are1,800 first-episode schizophrenia patients recruited from 19 hospitals, and six groups as with sub-project 1. The assessments (timepoint and content) are conducted as in sub-project 1. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia;Duration of illness less than 3 years with current symptoms exacerbation;Male and female with aged 17 to 65 years;
Key inclusion criteria (4 listed)
- Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia;
- Duration of illness less than 3 years with current symptoms exacerbation;
- Male and female with aged 17 to 65 years;
- Signed the study consent for participation
Key exclusion criteria (7 listed)
- Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
- Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
- Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
- Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
- The routine blood tests showing abnormal renal, liver function;
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 |
|---|---|---|
| antipsychotic medicationsolanzapine, risperidone, aripiprazole, amisulpride, ziprasidone, and haloperidol groups | Drug | treatment cohort, validation cohort |
| adjunctive groupantipsychotic plus placebo, antipsychotic plus sulforaphane(3 tables per day, consisting of 30 mg of SFN-glucosinolate per day), and antipsychotic plus minocycline(200mg per day) groups. | Drug | adjunctive group |
| metformin and lifestyle interventiondifferent dose metformin combines lifestyle intervention | Drug | metformin and lifestyle intervention for MetS, metformin and lifestyle prevention for high risk of MetS |
Primary outcome
Positive And Negative Syndrome Scale (PANSS)
Time frame: 8 weeks
The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point.
Clinical Global Impressions(CGI)
Time frame: 8 weeks
The change of Clinical Global Impressions(CGI):severity of illness(SI), global improvement(GI) and efficacy index(EI) before and after treatment at different follow up point.
Global Assessment Function(GAF)
Time frame: 8 weeks
The change of Global Assessment Function(GAF) before and after treatment at different follow up point.
MATRICS Consensus Cognitive Battery (MCCB) composite score
Time frame: 8 weeks
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure before and after treatment at different follow up point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 42972312Zhu Y, Yang Y, Wu R, Cao D, Jiang F. Association between baseline cognition and clinical response in first-episode schizophrenia. BMC Psychiatry. 2026 Aug 5;26(1):855. doi: 10.1186/s12888-026-08481-4.
- Derived from this study: PubMed 40055632Gao S, Xu Q, Han Y, Jiang J, Wu F, Peng T, Ling C, Ni S, Zhang R, Ming Y, Liu X, Xu X. Relationship between cognitive impairments and psychopathological symptoms in female schizophrenia subsequent to 8 weeks treatment with antipsychotic drugs. BMC Psychiatry. 2025 Mar 7;25(1):211. doi: 10.1186/s12888-025-06605-w.
- Derived from this study: PubMed 39049073Xie P, Shao T, Long Y, Xie W, Liu Y, Yang Y, Huang Y, Wu R, Deng Q, Tang H. Orlistat for the treatment of antipsychotic-induced weight gain: an eight-week multicenter, randomized, placebo-controlled, double-blind trial. Lipids Health Dis. 2024 Jul 24;23(1):225. doi: 10.1186/s12944-024-02214-w.
- Derived from this study: PubMed 37728803Zeng J, Zhang W, Lu X, Zhou H, Huang J, Xu Z, Liao H, Liang J, Liang M, Ye C, Sun T, Hu Y, She Q, Chen H, Guo Q, Yan L, Wu R, Li Z. The association of SOD and HsCRP with the efficacy of sulforaphane in schizophrenia patients with residual negative symptoms. Eur Arch Psychiatry Clin Neurosci. 2024 Aug;274(5):1083-1092. doi: 10.1007/s00406-023-01679-7. Epub 2023 Sep 20.
- Derived from this study: PubMed 37468932Long Y, Wu Q, Yang Y, Cai J, Xiao J, Liu Z, Xu Y, Chen Y, Huang M, Zhang R, Xu X, Hu J, Liu Z, Liu F, Zheng Y, Meng H, Wang Z, Tang Y, Song X, Chen Y, Wang X, Liu T, Wu X, Fang M, Wan C, Zhao J, Wu R. Early non-response as a predictor of later non-response to antipsychotics in schizophrenia: a randomized trial. BMC Med. 2023 Jul 19;21(1):263. doi: 10.1186/s12916-023-02968-7.
- Derived from this study: PubMed 33716817Xiao J, Huang J, Long Y, Wang X, Wang Y, Yang Y, Hei G, Sun M, Zhao J, Li L, Shao T, Wang W, Kang D, Liu C, Xie P, Huang Y, Wu R, Zhao J. Optimizing and Individualizing the Pharmacological Treatment of First-Episode Schizophrenic Patients: Study Protocol for a Multicenter Clinical Trial. Front Psychiatry. 2021 Feb 25;12:611070. doi: 10.3389/fpsyt.2021.611070. eCollection 2021.
- Derived from this study: PubMed 33692676Peng XJ, Hei GR, Li RR, Yang Y, Liu CC, Xiao JM, Long YJ, Shao P, Huang J, Zhao JP, Wu RR. The Association Between Metabolic Disturbance and Cognitive Impairments in Early-Stage Schizophrenia. Front Hum Neurosci. 2021 Feb 22;14:599720. doi: 10.3389/fnhum.2020.599720. eCollection 2020.
- Derived from this study: PubMed 32528286Huang J, Hei GR, Yang Y, Liu CC, Xiao JM, Long YJ, Peng XJ, Yang Y, Zhao JP, Wu RR. Increased Appetite Plays a Key Role in Olanzapine-Induced Weight Gain in First-Episode Schizophrenia Patients. Front Pharmacol. 2020 May 22;11:739. doi: 10.3389/fphar.2020.00739. eCollection 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Schizophrenia and Metabolic Syndrome, run by Central South University 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive And Negative Syndrome Scale (PANSS) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451734, which also lists 8 linked publications.
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 12 Aug 2021.