Double Blind, Placebo-controlled Study of Efficacy, Safety and Tolerance of Raloxifene as an Adjuvant Treatment for Negative Symptoms of Schizophrenia in Postmenopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
研究概览
简要总结
Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women.
This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Treatment period of 12 weeks.
The primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. The investigators also found improved response in some aspects of social functioning and neuropsychological functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia (DSM-IV criteria)
- •Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level > 20IU/L.
- •Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
- •Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
- •Patients have to give written informed consent to participate in the study.
排除标准
- •Patients with a substance abuse/dependence diagnosis in the previous six months.
- •Mental retardation.
- •Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
- •History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
- •Patients taking hormone replacement therapy.
- •Patients taking mood stabilizer medication that cannot be discontinued.
研究组 & 干预措施
sugar pill
干预措施: raloxifene (Drug)
raloxifene hydrochloride
Dose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks.
干预措施: raloxifene (Drug)
结局指标
主要结局
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
次要结局
- Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.