Schizophrenia Clinical Trial
— TAASOfficial title:
Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia
Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 Axis?mental 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; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Guangzhou Psychiatric Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Qingyun Yin |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score | From baseline to 12 weeks of treatment | No | |
Secondary | MATRICS Consensus Cognitive Battery(MCCB) factor score | From baseline to 12 weeks of treatment | No | |
Secondary | Positive and Negative Syndrome Scale(PANSS) total score | From baseline to 12 weeks of treatment | No | |
Secondary | Positive and Negative Syndrome Scale(PANSS) factor score | From baseline to 12 weeks of treatment | No | |
Secondary | Personal and Social Performance Scale(PSP) total score | From baseline to 12 weeks of treatment | No | |
Secondary | Clinical Global Impression(CGI) factor score | From baseline to 12 weeks of treatment | No | |
Secondary | Treatment Emergent Symptom Scale(TESS) factor score | From baseline to 12 weeks of treatment | No | |
Secondary | Functional magnetic resonance imaging(FMRI) | From baseline to 12 weeks of treatment | No |
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