Status:
COMPLETED
Effects of Buspirone Combined With Clozapine
Lead Sponsor:
Chuanfu Song
Collaborating Sponsors:
Wuhu Fourth People's Hospital affiliated with Bengbu Medical University
Conditions:
Schizophrenia
Eligibility:
All Genders
1-65 years
Phase:
EARLY_PHASE1
Brief Summary
This study aimed to evaluate the enhancing effects of different doses of buspirone on psychiatric symptoms and cognitive function in patients with schizophrenia. The investigators adopted a prospectiv...
Eligibility Criteria
Inclusion
- Aged 18-65 years;
- Meeting the diagnostic criteria for chronic schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Current remission of psychotic symptoms. The patients had a relatively stable mental state in the past 4 weeks, with a total score of ≤60 points and a score of ≤4 points on the Positive and Negative Syndrome Scale (PANSS)\[15\], and there were no signs of acute psychotic symptoms. To ensure that patients were included in the chronic phase, only patients who had been diagnosed with schizophrenia for ≥1 year were recruited, thus avoiding confusion with acute phase cases;
- Receiving monotherapy with antipsychotic drugs, such as clozapine.
Exclusion
- Pregnant or lactating women;
- Patients allergic to buspirone;
- Patients previously diagnosed with cognitive impairment, such as dementia or intellectual disability;
- Patients with a history of other brain injuries or diseases, such as stroke, traumatic brain injury, epilepsy or intracranial infection;
- Patients with severe liver or kidney insufficiency;
- Patients with severe physical diseases or other mental illnesses, such as bipolar disorder, major depressive disorder, alcohol or substance dependence;
- Patients with a history of using drugs that affect cognitive function during the study period or those who need to adjust the existing treatment regimen;
- Patients who are unable to cooperate with cognitive function tests or have poor treatment compliance.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06906224
Start Date
May 1 2022
End Date
December 30 2023
Last Update
April 2 2025
Active Locations (1)
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1
Wuhu Fourth People's Hospital affiliated with Bengbu Medical University
Wuhu, Anhui, China, 241002