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| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
| Sichuan University | OTHER |
| Capital Medical University | OTHER |
| Nanjing Medical University |
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Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high discontinue rate.To solve these problems, we provide practical and available psychosocial intervention. We hypothesize that there will be significant difference in the overall effectiveness between antipsychotic and antipsychotic combination with psychosocial intervention.
The study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status.
We plan to recruit 1400 patients at 10 china sites and randomly assign them to two group. the control group only receive antipsychotic and the study group receive antipsychotic combination with psychosocial intervention. The course is 12 months. Patients use one of the seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine, and aripitrazole)to the maintain treatment. The psychosocial intervention include psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. The primary aim is to delineate differences in the overall effectiveness of the two treatment model.The assessments include the outcome of symptomatology，neurobiology，social psychology，medical economics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | the comparator arm will only receive one of the seven antipsychotic |
|
| 2 | Experimental | the experimental group will receive one of the seven study drugs combination with psychosocial intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole | Drug | patient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment. |
| Measure | Description | Time Frame |
|---|---|---|
| the time to discontinued treatment and the rate of relapse/rehospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. |
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Inclusion Criteria:
Eligible patients were 16 to 50 years of age;
had received a diagnosed of schizophrenia in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV);
were confirmed to be clinically stable by the investigator (the total score ≤60 on the Positive and Negative Syndrome Scale [PANSS] or a decrease of fifty percent from acute period in the total score on PANSS)
and taken maintenance treatment with any one of the following seven oral antipsychotics:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Mental Health of The Second Xiangya Hospital, Central South University | Changsha | Hunan | 410011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25064681 | Derived | Zhang Z, Zhai J, Wei Q, Qi J, Guo X, Zhao J. Cost-effectiveness analysis of psychosocial intervention for early stage schizophrenia in China: a randomized, one-year study. BMC Psychiatry. 2014 Jul 26;14:212. doi: 10.1186/s12888-014-0212-0. | |
| 21369751 | Derived | Guo X, Fang M, Zhai J, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, Guo T, Xie S, Twamley EW, Jin H, Zhao J. Effectiveness of maintenance treatments with atypical and typical antipsychotics in stable schizophrenia with early stage: 1-year naturalistic study. Psychopharmacology (Berl). 2011 Aug;216(4):475-84. doi: 10.1007/s00213-011-2242-3. Epub 2011 Mar 3. |
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| OTHER |
| Jiangxi Mental Hospital | UNKNOWN |
| Hunan Mental Hospital | OTHER |
| Guangzhou Mental Hospital | OTHER |
| Chongqing Metal Institute | UNKNOWN |
| Henan Mental Hospital | UNKNOWN |
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|
| psychosocial intervention | Behavioral | the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy. |
|
| 20819983 | Derived | Guo X, Zhai J, Liu Z, Fang M, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, He X, Guo T, Xie S, Wu R, Xue Z, Chen J, Twamley EW, Jin H, Zhao J. Effect of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia: A randomized, 1-year study. Arch Gen Psychiatry. 2010 Sep;67(9):895-904. doi: 10.1001/archgenpsychiatry.2010.105. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002746 | Chlorpromazine |
| D013469 | Sulpiride |
| D003024 | Clozapine |
| D000077152 | Olanzapine |
| D018967 | Risperidone |
| D000069348 | Quetiapine Fumarate |
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003984 | Dibenzazepines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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