The Effect of a Single Dose of Lamotrigine on Brain Function in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Neural function
研究概览
简要总结
This study will test whether a single dose of Lamotrigine (300mg) exerts significant effects on emotional processing, cognitive ability and neural activity in healthy volunteers compared to placebo.
详细描述
Glutamate has been implicated in the aetiology of mood disorders and there is current interest in developing novel agents targeting this system. However, the role of glutamate in human emotional function is relatively unknown. Lamotrigine's pharmacological profile involves a blockade of voltage-gated sodium channels, leading to an inhibition in the release of glutamate and resulting in a general inhibitory effect on cortical neuronal function.
The current study plans to investigate the effects of modifying glutamate on emotional processing, cognitive function and neural activity. For this, 36 healthy volunteers will be recruited to the study and randomised to receive a single dose of lamotrigine (300 mg) or placebo. Two hours after drug administration, the effects of emotional processing via the use of cognitive tasks will be assessed using fMRI. This will be followed by an emotional test battery that will measure aspects of cognitive function as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Aged 18-40 years
- •Willing and able to give informed consent for participation in the study
- •Sufficiently fluent English to understand and complete the task
排除标准
- •Current usage of psychoactive medication
- •Current usage of the contraceptive pill
- •Any past or current Axis 1 DSM-IV psychiatric disorder
- •Significant medical condition
- •Current pregnancy or breastfeeding
- •Current or past history of drug or alcohol dependency
- •Participation in a psychological or medical study involving the use of medication within the last 3 months
- •Previous participation in a study using the same, or similar, emotional processing tasks
- •Smoker > 5 cigarettes per day
- •Typically drinks > 6 caffeinated drinks per day
- •Takes folic acid supplements
- •History of recurrent allergies and rashes
- •Contraindication to MRI (e.g. claustrophobia and metallic implants)
研究组 & 干预措施
Placebo
Placebo capsule: identical appearance to experimental capsule. In healthy volunteers.
干预措施: Placebos (Drug)
Lamotrigine
Single dose of Lamotrigine (300mg - capsule). In healthy volunteers.
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Neural function
时间窗: Data reporting and analysis to be completed within 1 year following study completion.
fMRI checkerboard analysis
次要结局
- Emotional Processing and Cognitive Function(Data reporting and analysis to be completed within 6 months following study completion.)