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NCT Number: NCT06906224

Effects of Buspirone Combined With Clozapine

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

1 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wuhu Fourth People's Hospital affiliated with Bengbu Medical University

Wuhu, Anhui, 241002, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control group (clozapine, placebo)

Drug

Patients received oral clozapine (Jiangsu Pharmaceutical Co., Ltd., Approval No. H32022963) in combination with a placebo. Each dose of the placebo was 1 mg, taken three times a day.

Low-dose group (buspirone tablets, clozapine)

Drug

Patients received oral buspirone tablets (Jiangsu Enhua Pharmaceutical Co., Ltd., Approval No. H19991024) in combination with clozapine. The total daily dose of buspirone was 15 mg, divided into three administrations. The dose remained unchanged throughout the entire study period.

High-dose group (buspirone tablets, clozapine)

Drug

Patients received oral buspirone tablets in combination with clozapine. The initial total daily dose of buspirone was 15 mg, divided into three administrations. One week later, the dose was increased to a total daily dose of 30 mg, also divided into three administrations.

Primary outcomes

  1. Assessment of psychiatric symptoms

    Time frame: 4 weeks, 8 weeks and 12 weeks

    The PANSS was used to evaluate the severity of psychiatric symptoms in schizophrenia. The PANSS is composed of three subscales: Positive Scale, Negative Scale and General Psychopathology Scale. Each item is rated on a scale from 1 to 7, with a total score ranging from 0 to 125; lower scores indicate milder symptoms.

  2. Assessment of cognitive function

    Time frame: 4 weeks, 8 weeks and 12 weeks

    Cognitive function was assessed using the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)[17]. The RBANS assesses five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention and delayed memory. Each domain contains specific tasks and scoring criteria.

  3. Adverse event records

    Time frame: 4 weeks, 8 weeks and 12 weeks

    Throughout the entire study period, detailed records were made of all adverse events reported by patients, including the type of the event, the occurrence time, the duration and the severity level. Particular attention was paid to the potential adverse reactions associated with the combined use of medications, such as drowsiness and dizziness

Sponsors and collaborators

Lead sponsor

Chuanfu Song

Other

Collaborators

  • Wuhu Fourth People's Hospital affiliated with Bengbu Medical University

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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