SchizophreniaEarly Phase 1NCT06906224

Effects of Buspirone Combined With Clozapine

A Early Phase 1 study testing Low-dose group (buspirone tablets, clozapine) and High-dose group (buspirone tablets, clozapine) in people with Schizophrenia, run by Chuanfu Song at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 year to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Low-dose group (buspirone tablets, clozapine) and High-dose group (buspirone tablets, clozapine)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteChina
Study dates: 1 May 2022to 30 Dec 2023
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Wuhu Fourth People's Hospital affiliated with Bengbu Medical University
Wuhu, Anhui, 241002

Other trials in China

About this study

Official 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

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
Being tested: Control group (clozapine, placebo), Low-dose group (buspirone tablets, clozapine), High-dose group (buspirone tablets, clozapine)
Keywords: Buspirone, schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06906224
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: High-dose group (buspirone tablets, clozapine)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 4 weeks, 8 weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202230 Dec 2023

First posted2 Apr 2025
Study start1 May 2022
Primary completion10 Nov 2023
Study completion30 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06906224
Sponsor's protocol ID: Wuhu4thPeopleH001
Status last verified: Mar 2025
First submitted: 19 Mar 2025
Last updated: 2 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT06906224
Acronym / sponsor ID: Wuhu4thPeopleH001
Conditions: Schizophrenia
Keywords: Buspirone, schizophrenia
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Chuanfu SongUniversity, hospital or other
Collaborators: Wuhu Fourth People's Hospital affiliated with Bengbu Medical University
Study start: 1 May 2022 (actual)
Primary completion: 10 Nov 2023 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 2 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Control group	Active comparator	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. 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.
Low-dose group	Active comparator	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.
High-dose group	Experimental	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.

Who may qualify

Ages: 1 year to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Control group
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	Low-dose group
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.	Drug	High-dose group

Primary outcome

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.
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.
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
Individual participant dataSharing planned: No

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Low-dose group (buspirone tablets, clozapine) and High-dose group (buspirone tablets, clozapine) in people with Schizophrenia, run by Chuanfu Song at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of psychiatric symptoms (time frame: 4 weeks, 8 weeks and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06906224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.