IRCT20120314009297N7招募中3 期
Study of the efficacy and safety of ondansetron as an adjuvant to antipsychotics in patients with chronic schizophrenia: A randomized, double-blind, placebo-controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- Male
入选标准
- •18-65 years old male patients
- •Patients with a diagnosis of schizophrenia based on DSM-5 criteria for at least two years who should still be symptomatic despite treatment with antipsychotic medications.
- •Patients should be treated with antipsychotic medications for at least one year, and the type and dose of their antipsychotic medications should remain constant for the last three months.
- •If they are taking medications such as mood stabilizers or antidepressants with their antipsychotic treatment regimen, their type and dose will remain the same for three months before the start of the study and during the study.
- •If they are taking anticholinergic drugs (which include bipyridine or trihexylphenidyl) in combination with their antipsychotic treatment regimen for treatment or prevention the Movement side effects of antipsychotics, the type and dose of them remain stable for three months before the start of and during the study.
排除标准
- •Going to the acute phase of the disease means a 20% increase in the overall score of PANSS (Scizospheria positive and negative evaluation criteria)
- •Patients with acute suicidal behavior or a history of suicide last year, associated psychiatric disorders such as schizo-effective or other psychotic disorders, mental retardation or other cognitive impairment, bipolar disorder and depression, anxiety disorders such as current panic disorder or obsessive-compulsive disorder, Post-traumatic stress disorder, eating disorder
- •History of substance abuse dependence (substance dependence criteria DSM-5) or abuse of substances in the three months prior to the start of the study or positive urine screening test for the substance at the beginning of the study.
- •Patients under ECT in the last six months
- •People with thoughts or actions to harm themselves or others during the study or in the 6 months before the study
- •Patients with neurological disorders such as dementia, delirium, uncontrolled seizures, head trauma, seizure disorder (other than fever-related) and neurodegenerative diseases (such as Alzheimer's, Parkinson's, Stroke, and multiple sclerosis)
- •People with conduction disorders of the heart and other medical / uncontrolled underlying diseases
- •Patients with a history of NMS
- •Patients treated with drugs that affect the patient's cognitive status are based on the criteria of Drugs on the Anticholinergic Burden (ACB) scale (17), such as drugs with anticholinergic properties (except biperidin and trihexifenidyl), hypnotic antihistamines. , Antidepressants
- •Patients with sensitivity to androsterone or other components of the drug or placebo
- •Patients with endangered drug use in the last 6 months
研究者
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