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A Randomized Single-blind controlled trial of the Safety and Effectiveness of Different Durations and Doses of the Combined Treatment of Buspirone and Oral Antipsychotics to Improve the Cognitive Function of Women with Chronic Schizophrenia, and the Application of fNIRS in the Evaluation of Executive Functions

A Randomized Single-blind controlled trial of the Safety and Effectiveness of Different Durations and Doses of the Combined Treatment of Buspirone and Oral Antipsychotics to Improve the Cognitive Function of Women with Chronic Schizophrenia, and the Application of fNIRS in the Evaluation of Executive Functions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049481
Enrollment
Unknown
Registered
2021-08-02
Start date
2021-02-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Buspirone 15mg group:The original antipsychotics combined with buspirone 15mg/d group
Buspirone 30mg group:The original antipsychotics combined with buspirone 30mg/d group
Buspirone 40mg group:The original antipsychotics combined with buspirone 40mg/d group
Healthy controls:Normal person

Sponsors

Xi'an Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy controls: (1) Signed the written informed consent. (2) Female, 18 = age = 50 years old. (3) 9 years of education and above, able to understand and read Chinese characters. Patients with schizophrenia: (1) Signed the written informed consent. (2) Female, 18 = age = 50 years old. (3) 9 years of education and above, able to understand and read Chinese characters. (4) Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for schizophrenia. (5) Has experienced an acute treatment period of 4-6 weeks. Take a stable dose of non-classical antipsychotics for at least 2 weeks. The total score of the Positive and Negative Syndrome Scale (PANSS) is less than 60 points. Hamilton Depression Rating Scale (HAMA-24) score = 8 points. Hamilton Anxiety Rating Scale (HAMA-14) score = 7 points. A stable cognitive state has been reached. (6) The MATRICS Consensus Cognitive Battery (MCCB) or similar cognitive assessment work has not been performed within 6 months. (7) Did not take buspirone within 1 month.

Exclusion criteria

Exclusion criteria: Healthy controls: (1) Suffer from psychiatric diseases, such as bipolar disorder, depression, obsessive-compulsive disorder, etc. (2) People with brain trauma who have neurological disease or loss of consciousness for more than 1 hour. Suffer from brain organic mental disorders (e.g. mental retardation, Alzheimer's disease, Parkinson's disease, vascular dementia, cognitive disorders caused by brain trauma, etc.). (3) Those who have a history of alcohol or drug abuse. (4) Cannot fully understand the test instruction and the informed consent form. Patients with schizophrenia: (1) Be diagnosed or co-suffer from mental disorders such as bipolar disorder, depression, obsessive-compulsive disorder, etc. (2) People who are dependent on alcohol or substances in the past 6 months. (3) People with clinical neurological diseases or head trauma (loss of consciousness for more than 1 hour). Suffer from brain organic mental disorders (e.g. mental retardation, Alzheimer's disease, Parkinson's disease, vascular dementia, cognitive disorders caused by brain trauma, etc.). (4) Medical treatments currently accepted can interfere with cognitive assessment. (5) Use the following drugs: cognitive enhancers, anti-dementia drugs, lithium salts, tricyclic antidepressants, monoamine oxidase inhibitors. Use benzodiazepines, sedatives, or anticholinergic drugs within 12 hours of the scale and the fNIRS test. (6) Suffer from glaucoma, myasthenia gravis, leukopenia, liver and kidney dysfunction, abnormal liver function, pulmonary dysfunction, or allergy to buspirone. (7) Women who are pregnant, preparing for pregnancy or breast-feeding.

Design outcomes

Primary

MeasureTime frame
MATRICS Consensus Cognitive Battery;Near infrared spectroscopy;Positive and Negative Syndrome Scale;Hamilton Depression Rating Scale-24;Hamilton Anxiety Rating Scale-14;Barnes Akathisia Rating Scale;Rating Scale for Extrapyramidal Side-effects;Electrocardiogram;Blood routine;Biochemical tests;Blood concentration of buspirone;

Countries

China

Contacts

Public ContactCui Meng

Xi'an Mental Health Center

995452785@qq.com+86 13891983933

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026