TAAS: Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

Sponsor

Qingyun Yin (Other)

Overall Status

Unknown status

CT.gov ID

NCT02040883

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole Drug: Tandospirone	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group 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 Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status. Other Names: AAPD
Experimental: Study Group 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 Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status. Other Names: AAPD Drug: Tandospirone Tandospirone，30mg per day Other Names: Sediel

Arm

Intervention/Treatment

Active Comparator: Control Group

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

Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.

Other Names:

AAPD

Experimental: Study Group

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

Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.

Other Names:

AAPD

Drug: Tandospirone

Tandospirone，30mg per day

Other Names:

Sediel

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;