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Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia (TAAS)

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ClinicalTrials.gov Identifier: NCT02040883
Recruitment Status : Unknown
Verified January 2014 by Qingyun Yin, Guangzhou Psychiatric Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 20, 2014
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Qingyun Yin, Guangzhou Psychiatric Hospital

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole Drug: Tandospirone Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia
Study Start Date : February 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: 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 Name: AAPD

Drug: Tandospirone
Tandospirone,30mg per day
Other Name: Sediel




Primary Outcome Measures :
  1. 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 Measures :
  1. MATRICS Consensus Cognitive Battery(MCCB) factor score [ Time Frame: From baseline to 12 weeks of treatment ]
  2. Positive and Negative Syndrome Scale(PANSS) total score [ Time Frame: From baseline to 12 weeks of treatment ]
  3. Positive and Negative Syndrome Scale(PANSS) factor score [ Time Frame: From baseline to 12 weeks of treatment ]
  4. Personal and Social Performance Scale(PSP) total score [ Time Frame: From baseline to 12 weeks of treatment ]
  5. Clinical Global Impression(CGI) factor score [ Time Frame: From baseline to 12 weeks of treatment ]
  6. Treatment Emergent Symptom Scale(TESS) factor score [ Time Frame: From baseline to 12 weeks of treatment ]
  7. Functional magnetic resonance imaging(FMRI) [ Time Frame: From baseline to 12 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040883


Contacts
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Contact: Qingyun Yin qingyun2000@hotmail.com

Locations
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China, Guangdong
Guangzhou Psychiatric Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510170
Contact: qingyun Yin       qingyun2000@hotmail.com   
Sponsors and Collaborators
Qingyun Yin
Investigators
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Principal Investigator: Qingyun Yin Guangzhou Psychiatric Hospital

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Responsible Party: Qingyun Yin, Professor, Guangzhou Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT02040883     History of Changes
Other Study ID Numbers: DSPC-SED20130516
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014
Keywords provided by Qingyun Yin, Guangzhou Psychiatric Hospital:
Schizophrenia
Tandospirone
Cognitive Therapy
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Risperidone
Antipsychotic Agents
Aripiprazole
Quetiapine Fumarate
Ziprasidone
Tandospirone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents