Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

Schizophrenia Clinical Trial

— TAAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02040883
• Other study ID #: DSPC-SED20130516
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 14, 2014
• Last updated: January 17, 2014
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Guangzhou Psychiatric Hospital
• Contact: Qingyun Yin
• Email: qingyun2000[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole
Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.
• Tandospirone
Tandospirone,30mg per day

Locations

Country	Name	City	State
China	Guangzhou Psychiatric Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Qingyun Yin

Country where clinical trial is conducted

China, 

Outcome

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