A 10-week, Randomized, Double-Blind, Placebo-Controlled Trial of a Neurocognition Enhancing Agent(Pregnenolone) in Patients With Schizophrenia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement in composite score of the MATRICS Consensus Cognitive Battery (MCCB) and BACS.
研究概览
简要总结
The purpose of this study is to determine whether pregnenolone will demonstrate significant improvements in cognitive functioning and negative symptoms compared to patients receiving placebo.
详细描述
Aims:
Schizophrenia is one of the most disabling disorders to afflict mankind. Despite the low lifetime prevalence of schizophrenia (1% world-wide), it has an enormous burden in both economic cost and human suffering. There is currently no cure for schizophrenia and its cause is not well understood. Patients with schizophrenia also suffer from negative symptoms (loss of drive, apathy, poverty of speech) and severe cognitive impairments especially with memory, attention, processing of information - the latter of which is most robustly correlated with their role functioning in the community. Addressing these impairments with effective interventions is thus critically important but at this present moment, there is no effective treatment. Recent emerging data from animal studies and a pilot study on small group of patients with schizophrenia suggest that neurosteroids such as pregnenolone may be relevant to schizophrenia pathophysiology and treatment of neurocognitive impairments. This study will be a 10-week randomised double-blind placebo-controlled trial of the efficacy and safety of pregnenolone. Our hypothesis is patients with schizophrenia randomized to pregnenolone will demonstrate significant improvements in cognitive functioning and negative symptoms compared to patients receiving placebo. The primary aims of the study are to demonstrate the efficacy of pregnenolone in comparison to placebo in patients with schizophrenia which are assessed by changes (from baseline) in the composite score of the MATRICS Consensus Cognitive Battery (MCCB), BACS and the Scale for Assessment of Negative Symptoms (SANS). Changes in functionality will be assessed by the University of California Performance Based Skills Assessment (UPSA). Safety will be assessed with laboratory tests, well established scales for side effects as well as with a side-effects checklist.
Objectives:
To demonstrate the efficacy of pregnenolone in comparison to placebo in patients with schizophrenia and with cognitive impairment from randomization (Week 2) to Week 10 by using MATRICS Consensus Cognitive Battery, BACS, Scale for Assessment of Negative Symptoms, Performance Based Skills Assessment - Brief Version and Clinical Global Impression -Improvement (CGI-I).Additional safety data on pregnenolone in patients with schizophrenia will be provided.
Methodology:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 21 to 65 years inclusively at screening.
- •Current diagnosis of Schizophrenia established by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for at least 1 year prior to screening.
- •Subjects can be either inpatients or outpatients.
- •Provision of written informed consent.
- •Able to understand and comply with the requirements of the study, as judged by the investigator.
- •Subjects have to be treated with a first generation and/or second generation antipsychotic for the previous 8 weeks or longer, with no change in dose in ≥ 4 weeks at screening.
- •Women of childbearing potential (less than two years post-menopausal or not surgically sterile), must have a negative urine pregnancy test at screening - and must use a highly effective method of birth control for at least one month prior to screening such as barrier methods, implants, sexual abstinence or vasectomised partner.
排除标准
- •Subjects with a DSM-IV diagnosis of alcohol or other substance dependence (other than nicotine) within the last month.
- •Subjects with a history of significant head injury/trauma, with loss of consciousness (LOC) for more than 1 hour, recurring seizures resulting from the head injury, clear cognitive sequelae of the injury, or cognitive rehabilitation following the injury.
- •Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g., unstable angina, seizures, cerebrovascular accident, decompensate congestive heart failure, CNS infection, HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
- •Active medical conditions that are minor or well-controlled are not exclusionary if they are not likely to affect risk to the patient or the study results.
- •Patients with hormone-sensitive tumours (such as breast, uterine, or prostate cancer) will be excluded.
- •Clinically significant abnormalities in physical examination, ECG, or laboratory assessments.
- •Pregnant women or sexually active women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (urine pregnancy test will be performed at baseline and week 10 of the study to exclude pregnancy).
- •Women who are breast-feeding.
- •ECT treatment within the last 3 months.
- •Use of oral contraceptives or other hormonal supplementation such as oestrogen.
- •Subjects who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- •Known allergy to study medication.
- •Participation in another drug trial within 4 weeks of this study.
研究组 & 干预措施
Pregnenolone
干预措施: Pregnenolone (Drug)
Sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in composite score of the MATRICS Consensus Cognitive Battery (MCCB) and BACS.
时间窗: 10 weeks
Improvement of negative symptoms as assessed by the Scale for Assessment of Negative Symptoms (SANS).
时间窗: 10 weeks
次要结局
- To provide additional safety data on pregnenolone in patients with schizophrenia via reported serious and non serious adverse events.(10 weeks)
- Improvement of functional outcome by the University of California Performance Based Skills Assessment (UPSA-B)at Week 2, 6 and 10.(10 weeks)
- Efficacy outcome variables will be evaluated by the Clinical Global Impression -Improvement (CGI-I) score at week 2 to week 10.(10 weeks)
研究者
Chong Siow Ann
Associate Professor
National Research Foundation, Singapore