Role of Anti-Inflammatory Agents in Patients With Schizophrenia
关键词
抽象
日期
| 最后验证: | 07/31/2019 |
| 首次提交: | 06/27/2009 |
| 提交的预估入学人数: | 06/28/2009 |
| 首次发布: | 06/29/2009 |
| 上次提交的更新: | 08/01/2019 |
| 最近更新发布: | 08/04/2019 |
| 实际学习开始日期: | 05/31/2009 |
| 预计主要完成日期: | 08/31/2009 |
| 预计完成日期: | 08/31/2010 |
状况或疾病
干预/治疗
Drug: Ondansetron
Drug: Simvastatin
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Ondansetron | Drug: Ondansetron ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose |
| Active Comparator: Simvastatin | Drug: Simvastatin Simvastatin added to TAU Simvastatin 20mg taken as once daily dose |
| Placebo Comparator: Placebo | Drug: Placebo Placebo added to TAU |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder 2. competent and willing to give informed consent 3. stable on medication 4 weeks prior to baseline 4. able to take oral medication and likely to complete the required evaluations 5. female participants of child bearing age must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication. Exclusion Criteria: 1. Relevant medical illness [renal and hepatic] in the opinion of the investigators 2. history of high alcohol intake 3. any change of psychotropic medications within the previous six weeks 4. diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria 5. pregnant or breast-feeding. |
结果
主要结果指标
1. acceptability and tolerability of simvastatin and ondansetron added to TAU [3 months]
次要成果指标
1. simvastatin and ondansetron added to TAU prevents the accumulation of negative symptoms in patients with schizophrenia [3 months]
2. simvastatin and ondansetron added to TAU prevents cognitive decline [3 months]
3. To compare the effect size [3 months]
