Efficacy of Pregnenolone in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- SANS - Scale for the Assessment of Negative Symptoms
研究概览
简要总结
Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.
详细描述
Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Diagnosis of schizophrenia or schizoaffective disorder
- •No new medication for past 3 months and stable dose for past 4 weeks
- •SANS (Negative symptom) score of 20 or above
排除标准
- •Significant dementia or head trauma.
- •Seizure during past year.
- •Substance dependence in past 6 months or positive urine drug screen.
- •History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
- •Steroid metabolism disorder, e.g.Cushings or Addison's disease.
- •Taking steroids other than birth control or post-menopausal hormones.
- •Women who are pregnant or nursing.
结局指标
主要结局
SANS - Scale for the Assessment of Negative Symptoms
时间窗: every month for 4 months
次要结局
- Quality of Life(every two months for four months)
研究者
Jason Kim
Assistant Professor of Psychiatry
Weill Medical College of Cornell University