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Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia
With atypical antipsychotics for the control group, evaluate cognitive function in schizophrenia patients with antipsychotics combined 5-Hydroxytryptamine 1A (5-HT1A) receptor partial agonist tandospirone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Treated with a stable dose of an AAPD for at least three months before enrollment; Atypical antipsychotic drugs(AAPDs): Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole |
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| Study Group | Experimental | Atypical antipsychotic drugs(AAPDs) and Tandospirone ; Atypical antipsychotic drugs(AAPDs) ,treated with a stable dose of an AAPD for at least three months before enrollment; AAPD: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole; Tandospirone, 30mg per day; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole | Drug | Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score | From baseline to 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MATRICS Consensus Cognitive Battery(MCCB) factor score | From baseline to 12 weeks of treatment | |
| Positive and Negative Syndrome Scale(PANSS) total score | From baseline to 12 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyun Yin | Contact | qingyun2000@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingyun Yin | Guangzhou Psychiatric Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Psychiatric Hospital | Guangzhou | Guangdong | 510170 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| C055267 | tandospirone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Tandospirone | Drug | Tandospironeļ¼30mg per day |
|
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| Positive and Negative Syndrome Scale(PANSS) factor score |
| From baseline to 12 weeks of treatment |
| Personal and Social Performance Scale(PSP) total score | From baseline to 12 weeks of treatment |
| Clinical Global Impression(CGI) factor score | From baseline to 12 weeks of treatment |
| Treatment Emergent Symptom Scale(TESS) factor score | From baseline to 12 weeks of treatment |
| Functional magnetic resonance imaging(FMRI) | From baseline to 12 weeks of treatment |