Effects of Buspirone Combined With Clozapine

NCT06906224 | Completed Early Phase 1

• 1 other identifier: Wuhu4thPeopleH001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Buspirone; schizophrenia

Outcome Measures

Primary Outcomes (3)

• Assessment of psychiatric symptoms

  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.

  4 weeks, 8 weeks and 12 weeks

• Assessment of cognitive function

  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.

  4 weeks, 8 weeks and 12 weeks

• Adverse event records

  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

  4 weeks, 8 weeks and 12 weeks

Study Arms (3)

Control group

ACTIVE COMPARATOR

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. Use of placebo: This study employed a double-blind design. Patients in the control group received clozapine monotherapy and took a placebo concurrently. The placebo was identical to buspirone tablets in terms of appearance, shape, colour and packaging to guarantee the double-blind nature of the study. The placebo was custom-made by a third-party pharmaceutical company. Its label only stated 'placebo' and was exactly the same as that of buspirone tablets. This design was intended to eliminate the potential impact of the placebo effect on the study results.

Drug: Control group (clozapine, placebo)

Low-dose group

ACTIVE COMPARATOR

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.

Drug: Low-dose group (buspirone tablets, clozapine)

High-dose group

EXPERIMENTAL

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.

Drug: High-dose group (buspirone tablets, clozapine)

Interventions

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.

Control group

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.

Low-dose group

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.

High-dose group

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chuanfu Song: lead
• Wuhu Fourth People's Hospital affiliated with Bengbu Medical University: collaborator

Study Sites (1)

Wuhu Fourth People's Hospital affiliated with Bengbu Medical University

Wuhu, Anhui, 241002, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Control Groups; Clozapine; Population Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 2, 2025
• Study Start: May 1, 2022
• Primary Completion: November 10, 2023
• Study Completion: December 30, 2023
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)