Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

Phase 4

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole; Drug: Tandospirone

• Registration Number: NCT02040883
• Lead Sponsor: Qingyun Yin

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

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-17
• Last Update Submitted: 2014-01-17
• Study First Posted: 2014-01-20
• Last Update Posted: 2014-01-20
• Study Start: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole	Treated with a stable dose of an AAPD for at least three months before enrollment; Atypical antipsychotic drugs(AAPDs): Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole
Study Group	Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole	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;
Study Group	Tandospirone	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;

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical Global Impression(CGI) factor score	From baseline to 12 weeks of treatment
MATRICS Consensus Cognitive Battery(MCCB) factor score	From baseline to 12 weeks of treatment
Personal and Social Performance Scale(PSP) total 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
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

Trial Locations

Locations (1)

Guangzhou Psychiatric Hospital; 🇨🇳 Guangzhou, Guangdong, China