NCT06906224CompletedEarly phase 1
Effects of Buspirone Combined With Clozapine
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 19 Mar 2025
- Start date
- 1 May 2022
- Primary completion date
- 10 Nov 2023
- Lead sponsor
- Chuanfu Song
- Diseases
- Schizophrenia
- NCT number
- NCT06906224
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 46
- From 1 May 2022 to the primary completion date, 10 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously diagnosed with cognitive impairment, such as dementia or intellectual disability;
Other illness
- Patients allergic to buspirone;
- 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;
Other
- Pregnant or lactating women;
- Patients who are unable to cooperate with cognitive function tests or have poor treatment compliance.
Who the study is looking for
- 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.
Age in the registry: 1 year to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhu Fourth People's Hospital affiliated with Bengbu Medical University Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.