MedTrace Logo

Effects of Buspirone Combined With Clozapine

NCT06906224 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-04-02

No results posted yet for this study

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

Interventions

DRUG

Control group (clozapine, placebo)

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.

DRUG

Low-dose group (buspirone tablets, clozapine)

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

High-dose group (buspirone tablets, clozapine)

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • Chuanfu Song

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-11-10
Completion
2023-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906224 on ClinicalTrials.gov