Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

Study Overview
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Brief Summary
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Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia

Detailed Description
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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

Official Title
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Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole
* Drug: Tandospirone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders-IV Edition (DSM-IV) diagnostic criteria for schizophrenia patients. 18-65 years (including 18 and 65), male or female. Treated with a stable dose of an AAPD for at least three months. Informed consent was obtained (if the patient is in the acute phase of schizophrenia, does not have the capacity, their guardians need sign informed consent). PANSS negative score ≤60. Exclusion Criteria: Combined AxisⅠmental illness other than schizophrenia; Taking a mood stabilizer, antidepressants, anticholinergic or anxiolytic drugs, and other drugs improve cognitive function; Suicidal tendencies; Have severe or unstable heart, liver, kidney, endocrine, blood and other medical disease patients Clinically significant ECG or laboratory abnormalities were Glaucoma and epilepsy; Unsupervised or unable to take prescribed medication; History of alcohol and drug abuse; Allergic; Pregnant or lactating woman; Patients participate in other clinical trials during a month;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Treated with a stable dose of an AAPD for at least three months before enrollment; Atypical antipsychotic drugs(AAPDs): Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole | Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole<br>* Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.<br>* Other names: AAPD;|
| Experimental: Study Group<br>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; | Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole<br>* Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.<br>* Other names: AAPD;Drug: Tandospirone<br>* Tandospirone，30mg per day<br>* Other names: Sediel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Tandospirone, Cognitive Therapy