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Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia (TAAS)

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole
Tandospirone
Sponsored by
Qingyun Yin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Tandospirone, Cognitive Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Guangzhou Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm 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

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;

Outcomes

Primary Outcome Measures

Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score

Secondary Outcome Measures

MATRICS Consensus Cognitive Battery(MCCB) factor score
Positive and Negative Syndrome Scale(PANSS) total score
Positive and Negative Syndrome Scale(PANSS) factor score
Personal and Social Performance Scale(PSP) total score
Clinical Global Impression(CGI) factor score
Treatment Emergent Symptom Scale(TESS) factor score
Functional magnetic resonance imaging(FMRI)

Full Information

First Posted
January 14, 2014
Last Updated
January 17, 2014
Sponsor
Qingyun Yin
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1. Study Identification

Unique Protocol Identification Number
NCT02040883
Brief Title
Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia
Acronym
TAAS
Official Title
Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qingyun Yin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Tandospirone, Cognitive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm 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
Arm Title
Study Group
Arm Type
Experimental
Arm 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;
Intervention Type
Drug
Intervention Name(s)
Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole
Other Intervention Name(s)
AAPD
Intervention Description
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
Intervention Name(s)
Tandospirone
Other Intervention Name(s)
Sediel
Intervention Description
Tandospirone，30mg per day
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
MATRICS Consensus Cognitive Battery(MCCB) factor score
Time Frame
From baseline to 12 weeks of treatment
Title
Positive and Negative Syndrome Scale(PANSS) total score
Time Frame
From baseline to 12 weeks of treatment
Title
Positive and Negative Syndrome Scale(PANSS) factor score
Time Frame
From baseline to 12 weeks of treatment
Title
Personal and Social Performance Scale(PSP) total score
Time Frame
From baseline to 12 weeks of treatment
Title
Clinical Global Impression(CGI) factor score
Time Frame
From baseline to 12 weeks of treatment
Title
Treatment Emergent Symptom Scale(TESS) factor score
Time Frame
From baseline to 12 weeks of treatment
Title
Functional magnetic resonance imaging(FMRI)
Time Frame
From baseline to 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingyun Yin
Email
qingyun2000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyun Yin
Organizational Affiliation
Guangzhou Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Psychiatric Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510170
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qingyun Yin
Email
qingyun2000@hotmail.com

12. IPD Sharing Statement

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Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

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