Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

Overview

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

Full Title of Study: “Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2014

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

Interventions

  • 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.
  • Drug: Tandospirone
    • Tandospirone,30mg per day

Arms, Groups and Cohorts

  • 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
  • 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;

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Qingyun Yin
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Qingyun Yin, Professor – Guangzhou Psychiatric Hospital
  • Overall Official(s)
    • Qingyun Yin, Principal Investigator, Guangzhou Psychiatric Hospital
  • Overall Contact(s)
    • Qingyun Yin, qingyun2000@hotmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.