Efficacy and Safety of Pregnenolone Augmentation in the Management of Schizophrenia Patients: a Randomised Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).
研究概览
简要总结
Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is hypothesized that the combined effect of antipsychotic agents and pregnenolone would be beneficial in the treatment of negative,depressive, and cognitive symptoms.
详细描述
Either pregnenolone (30 mg/d or 200 mg/d), DHEA (400 mg/d)or placebo will be added to regular treatment for 8 weeks. Subjects will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. An extensive battery of research instruments will be used for assessment of the following domains of interest: psychopathology, insight, side effects, and cognitive functions. Plasma pregnenolone, DHEA(S), cortisol and other relevant steroids will be assayed at baseline, 2, 4, 6 and 8 weeks of treatment. Efficacy and safety of augmentation of antipsychotic treatment with pregnenolone will be analyzed.
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
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for schizophrenia or schizoaffective disorder
- •Ability and willingness to sign informed consent for participation in the study
排除标准
- •Evidence of organic brain damage, mental retardation, alcohol or drug abuse
- •Prostate nodules or cancer.
- •Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding.
- •History of ischemic cardiac disease.
- •Renal disease.
- •Hepatic dysfunction.
- •Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.
- •Women with a history of uterine cancer.
- •Patients with a known hypersensitivity to androgens.
- •Pregnant women.
结局指标
主要结局
The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).
The Positive and Negative Syndrome Scale.
The Scale for the Assessment of Negative Symptoms.
The Calgary Depression Scale for Schizophrenia.
The Hamilton Scale for Anxiety.
Extrapyramidal Symptom Rating Scale.
Barnes Akathisia Scale.
Abnormal Involuntary Movement Scale.
次要结局
- The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999).