Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02040883

Acronym

TAAS

Enrollment

100

Registered

2014-01-20

Start date

2014-02-28

Completion date

2014-12-31

Last updated

2014-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Tandospirone, Cognitive Therapy

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

Interventions

DRUGRisperidone/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.

DRUGTandospirone

Tandospirone，30mg per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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;

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactQingyun Yin

qingyun2000@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026