Clinical trial NCT02040883: Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia
Official title: Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Tandospirone
Cognitive Therapy
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2014-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia

Detailed description: 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

Eligibility criteria: 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;

Primary outcomes:
measure: Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score
timeFrame: From baseline to 12 weeks of treatment
Secondary outcomes:
measure: MATRICS Consensus Cognitive Battery(MCCB) factor score
timeFrame: From baseline to 12 weeks of treatment
measure: Positive and Negative Syndrome Scale(PANSS) total score
timeFrame: From baseline to 12 weeks of treatment
measure: Positive and Negative Syndrome Scale(PANSS) factor score
timeFrame: From baseline to 12 weeks of treatment
measure: Personal and Social Performance Scale(PSP) total score
timeFrame: From baseline to 12 weeks of treatment
measure: Clinical Global Impression(CGI) factor score
timeFrame: From baseline to 12 weeks of treatment
measure: Treatment Emergent Symptom Scale(TESS) factor score
timeFrame: From baseline to 12 weeks of treatment
measure: Functional magnetic resonance imaging(FMRI)
timeFrame: From baseline to 12 weeks of treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Psychiatric Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou Psychiatric Hospital
name: Qingyun Yin
role: PRINCIPAL_INVESTIGATOR
References: