Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia (TAAS)

January 17, 2014 updated by: Qingyun Yin

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
MATRICS Consensus Cognitive Battery(MCCB) factor score
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment
Positive and Negative Syndrome Scale(PANSS) total score
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment
Positive and Negative Syndrome Scale(PANSS) factor score
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment
Personal and Social Performance Scale(PSP) total score
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment
Clinical Global Impression(CGI) factor score
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment
Treatment Emergent Symptom Scale(TESS) factor score
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment
Functional magnetic resonance imaging(FMRI)
Time Frame: From baseline to 12 weeks of treatment
From baseline to 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingyun Yin

Investigators

  • Principal Investigator: Qingyun Yin, Guangzhou Psychiatric Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSPC-SED20130516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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