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| Name | Class |
|---|---|
| Wuhu Fourth People's Hospital affiliated with Bengbu Medical University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhu Fourth People's Hospital affiliated with Bengbu Medical University | Wuhu | Anhui | 241002 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D003024 | Clozapine |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| 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. |
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| 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. |
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| D008722 | Methods |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003710 | Demography |
| D011154 | Population Characteristics |