Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint
研究概览
简要总结
Comorbid substance abuse leads to many deleterious effects such as medical comorbidities and nonadherence, which is one of the most problematic issues. People with schizophrenia and substance use disorders (SUDs) are at an increased risk nonadherence compared to those who do not use alcohol and illicit drugs. The investigators propose that this new marketed injectable antipsychotic with many benefits over other available long acting injectable agents would be beneficial in the dually diagnosed population and may represent a specific schizophrenia subpopulation where long acting agents may be considered an important therapeutic option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between ages 18 and 64
- •Either gender
- •Meet DSM-IV-TR criteria for Schizophrenia or Schizoaffective Disorder.
- •Alcohol and/or cannabis use defined as a DSM-IV diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
- •Agree to take or use birth control during the study.
排除标准
- •Previous lack of response or serious adverse event to risperidone or paliperidone.
- •Currently on a long acting injectable antipsychotic.
- •A score of less than 10 on the Evaluation to Sign Consent (ESC).
- •Medical illnesses, which may compromise safe study participation.
- •Pregnant and lactating females.
- •QTc interval > 450 milliseconds males or > 470 milliseconds in females
- •Currently on acamprosate, naltrexone and disulfiram.
研究组 & 干预措施
Paliperidone
干预措施: Paliperidone (Drug)
结局指标
主要结局
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint
时间窗: 7 months
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint during six months of treatment. Improvement in psychotic symptoms will be measured by decrease in the Brief Psychiatric Rating Scale (BPRS) psychosis score. Improvement in negative symptoms will be measured by decrease in the Scale for the Assessment of Negative Symptoms (SANS) total score. Improvement in depressive symptoms will be measured by decrease in Calgary Depression Scale (CDS) total score.
次要结局
未报告次要终点
研究者
MPRC
Heidi Wehring, PharmD, BCPP
University of Maryland, Baltimore