Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

NCT ID: NCT02040883

Last Updated: 2014-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole

Intervention Type DRUG

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

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;

Group Type EXPERIMENTAL

Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole

Intervention Type DRUG

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

Intervention Type DRUG

Tandospirone,30mg per day

Interventions

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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.

Intervention Type DRUG

Tandospirone

Tandospirone,30mg per day

Intervention Type DRUG

Other Intervention Names

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AAPD Sediel

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingyun Yin

OTHER_GOV

Sponsor Role lead

Responsible Party

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Qingyun Yin

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qingyun Yin

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Psychiatric Hospital

Locations

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Guangzhou Psychiatric Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Qingyun Yin

Role: CONTACT

Facility Contacts

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qingyun Yin

Role: primary

Other Identifiers

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DSPC-SED20130516

Identifier Type: -

Identifier Source: org_study_id

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