Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia (TAAS)

Qingyun Yin

Status and phase: Unknown; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole; Drug: Tandospirone

Study type: Interventional

Funder types: Other

Identifiers

NCT02040883

DSPC-SED20130516

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole

Study Group

Experimental group

Description:

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;

Treatment:

Drug: Tandospirone

Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole