Clinical trial NCT06906224: Effects of Buspirone Combined With Clozapine
Official title: Effects of Different Doses of Buspirone Combined With Clozapine on Psychiatric Symptoms and Cognitive Function in Patients With Schizophrenia: A Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Keywords: Buspirone
schizophrenia
Lead sponsor: Wuhu Fourth People's Hospital affiliated with Bengbu Medical University
Sponsor class: OTHER
Collaborators: name: Wuhu Fourth People's Hospital affiliated with Bengbu Medical University
First posted: 2025-04-02
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 prospective, randomised, double-blind, placebo-controlled study design and included 46 patients with schizophrenia being treated at the Fourth People's Hospital of Wuhu. The patients were randomly divided into three groups: the control group, the low-dose group and the high-dose group. The control group received clozapine monotherapy, while the experimental groups received additional buspirone at different doses in addition to clozapine. The Positive and Negative Syndrome Scale (PANSS) and the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status were used to evaluate psychiatric symptoms and cognitive function.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Assessment of psychiatric symptoms
timeFrame: 4 weeks, 8 weeks and 12 weeks
measure: Assessment of cognitive function
timeFrame: 4 weeks, 8 weeks and 12 weeks
measure: Adverse event records
timeFrame: 4 weeks, 8 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhu City
country: China
facility: Wuhu Fourth People's Hospital affiliated with Bengbu Medical University
state: Anhui
Study officials:
References: