NCT01720095已完成3 期
A 1 Year Randomized, Controlled, Open-Label Study of the Impact of Flexible Doses of Niacin (NIASPAN) as an Adjunct to Antipsychotic Medication in the Treatment of First Episode Psychosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB
研究概览
简要总结
The purpose of this study is to help understand if by adding Niaspan FCT (study drug) to antipsychotic medications will it help maintain or improve cognitve 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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALL SUBJECTS
- •Must understand the nature of the study, must provide written informed consent prior to the conduct of any study procedures/assessments and are willing/able to participate in study procedures/assessments as specified in this protocol.
- •Must be between the ages of 18 - 35
- •Within one year of initial DSM 1V TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
- •Outpatients
- •Females of child bearing potential who have a negative serum pregnancy test prior to enrolment and agree to use a reliable method of birth control (use of oral contraceptives or Norplant; contraceptive injections; contraceptive patch; double barrier method; intrauterine devices; partner with vasectomy or abstinence) during the study and for one month following the last dose of study drug.
- •HEALTHY CONTROLS
- •Age-matched to experimental groups
排除标准
- •Due to their underlying mental disorder are considered by the investigator(s) to be unable to provide informed consent and/or unwilling or unable to participate in study procedures/assessments
- •Are judged by the investigator(s) (based on history, mental status examination or clinical impression) as being at significant risk of self-injurious/suicidal or violent/homicidal behaviour
- •Meet criteria for substance abuse or dependence (excluding nicotine and caffeine) as defined by DSM IV-TR at the time of screening and/or within the preceding 6 months
- •Have unstable medical, psychiatric, neurological or behavioural disorders that may interfere in the conduct or interpretation of the study.
- •Have a history of pre-existing liver dysfunction and/or at screening have abnormal liver function tests (ALT>2x upper limit of normal; AST>3x upper limit of normal; Bilirubin>1.5x upper limit of normal)
- •Have a past or current history of peptic ulcer, gout or bleeding problems
- •Have a past or current history of hypophosphatemia
- •Have a history of head injury resulting in loss of consciousness of > 5 minutes or other neurological disorder (e.g., seizures, stroke, MS)
- •Are currently taking a vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 100 mg/day.
- •Are currently receiving treatment with any of the following medications:
- •Anticoagulants
- •Antihypertensives
- •Are currently receiving treatment for Type 1 or Type 2 diabetes
- •Have a history of allergic reactions to NIASPAN or any of its non-medicinal ingredients (methylcellulose, povidone, stearic acid), niacin or nicotinic acid
- •Are currently participating in any other investigational drug study
- •Are a professional or staff member affiliated with the Nova Scotia Early Psychosis Program or are an immediate family member defined as spouse, parent, child, sibling, grandparent or grandchild
研究组 & 干预措施
Niaspan
Experimental
these are the first episode psychosis patients that are randomized to receive niaspan
干预措施: Niaspan (Drug)
结局指标
主要结局
standardized and experimental measures of attention, memory, and executive function. Measurement tools=MATRICS; DalCAB
时间窗: change in cognitive function from baseline to 3, 6, and 12 months
Outcomes will be measured by comparison of pre-treatment, post-treatment and twelve month
次要结局
未报告次要终点
研究者
研究点 (1)
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