Atypical Antipsychotics and P50 Sensory Gating
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- P50 Sensory Gating
研究概览
简要总结
This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.
详细描述
Schizophrenia is a devastating brain disorder. Most people with schizophrenia have difficulty filtering out unimportant auditory information. They have an inability to appropriately inhibit, or gate, sensory information that enters the ear. Standard treatments do not address this problem. When the drug ondansetron is taken in addition to typical antipsychotic drugs, P50 auditory gating improves. However, ondansetron has not been used with some of the newer, atypical antipsychotic drugs. This study will evaluate the effect of combining ondansetron with newer, atypical antipsychotic drugs on P50 auditory gating.
Participants in this double-blind study will be randomly assigned to receive either ondansetron or placebo for 3 months. Upon completion of the first 3 months, participants will be crossed over to receive the other treatment for an additional 3 months. All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole. Auditory gating will be assessed using computerized cognitive testing and functional magnetic resonance imaging (fMRI) at baseline and Months 3 and 6. Vital signs and evoked potentials will be assessed at Weeks 1, 3, and 6. Clinical symptoms and cognitive abilities will also be evaluated to determine the effectiveness of ondansetron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV criteria for schizophrenia
- •Stable, chronic schizophrenia
- •Currently taking atypical medications
- •Use of effective form of contraception throughout study
排除标准
- •History of any alcohol or drug abuse within 3 months of study start date
- •Any other major neurological disorders
- •History of or current head trauma
- •Any medical conditions affecting the central nervous system
- •Current epilepsy, asthma, migraine headache, previous myocardial infarction, stroke, diabetes, hypertension, narrow angle glaucoma, or neuromuscular illnesses
研究组 & 干预措施
Ondansetron followed by placebo
Participants will take ondansetron then placebo plus an atypical antipsychotic drug
干预措施: Ondansetron followed by placebo (Drug)
Placebo followed by Ondansetron
Participants will take placebo then ondansetron plus an atypical antipsychotic drug
干预措施: Placebo followed by Ondansetron (Drug)
结局指标
主要结局
P50 Sensory Gating
时间窗: Up to 3 hours
P50 Sensory Gating as measured by evoked potentials (response to stimuli, in this case, clicking sounds).The P50 potential was identified and measured using a computer algorithm. The amplitude of the P50 test wave was divided by the amplitude of the P50 conditioning wave, expressed as a percentage: the P50 ratio. Lower P50 ratios represent better outcomes.
Cognitive Testing
时间窗: Measured at Months 3 and 6
次要结局
未报告次要终点
