The Effects of ARA290 on the Cognitive and Neural Processing of Emotions in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- performance on information processing test battery, particularly emotion recognition
研究概览
简要总结
Studies on the hormone Erythropoietin (EPO) have indicated that EPO may have antidepressant properties. However, EPO may cause serious side-effects with repeated administration (thrombosis), which limits its usefulness as an antidepressant. ARA290 is a peptide that does not have the effects of EPO on blood cells but may still have its effect on brain function. In an attempt to replicate previous findings with (a single dose of) EPO in healthy volunteers, we study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers. We hypothesize that a single dose of ARA290 will lead to a positive shift in information processing compared to placebo, 7 days post-administration.
详细描述
SUMMARY Rationale: Studies on the cognitive and neuronal effects of a single administration of Erythropoietin (EPO) in healthy volunteers and in depressed patients have suggested that EPO may have antidepressant effects. Due to its haematopoietic effects, EPO may cause serious side-effects with repeated administration, which limits its usefulness as an antidepressant. ARA290 is a peptide that does not have the haematopoietic effects of EPO but may still have its neurotrophic effects.
Objective: To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.
Study design: Randomized double-blind placebo-controlled experiment. Study population: Male and female healthy volunteers, n= 36; 18-35 yr old. Intervention: One group receives a single dose of 2 mg ARA290, the other group receives placebo.
Main study parameters/endpoints:
- Behavioral study: Performance on an Emotional Test battery (ETB) which has been shown sensitive to antidepressant administration in healthy volunteers. The ETB includes a measure of facial expression recognition, emotional memory and attentional vigilance.
- Neuroimaging study: Neural processing of emotions, in particular amygdala, hippocampal and VMPFC response to viewing facial stimuli expressing negative versus positive emotions.
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, Investigator, Outcomes Assessor)
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
- •Dutch-speaking
- •Age 18-35
- •Right-handedness
- •BMI 18 to 33 kg/m2
排除标准
- •Major physical illness, such as diabetes, thyroid disease, epilepsy, stroke, multiple sclerosis, pituitary disease, or any other serious medical condition.
- •Any current or past psychiatric disorder, including subclinical claustrophobia if severe enough to cause anxiety during scanning.
- •Using medication likely to interfere with the study, including OTC (over the counter) medication (e.g., St John's Wort) and benzodiazepines.
- •Pregnancy or breastfeeding
- •Use of any nicotine products or soft drugs (hash, marihuana) in the three months prior to the study
- •Any hard drug use (including XTC) (lifetime)
- •Alcohol use of more than 14 units per week or more than 4 units on any day during the week prior to the study or during the study period.
研究组 & 干预措施
ARA290
11-amino acid, linear peptide ARA290; intravenous injection with 2 mg ARA290 (single dosage).
干预措施: ARA290 (Drug)
Placebo
saline (NaCl 0.9%)
干预措施: Placebo (Drug)
结局指标
主要结局
performance on information processing test battery, particularly emotion recognition
时间窗: 1 week
Performance on an Emotional Test battery (ETB) which has been shown sensitive to antidepressant administration in healthy volunteers. The ETB includes a measure of facial expression recognition, emotional memory and attentional vigilance.
次要结局
- • Performance on a task of working memory(1 week)
研究者
Willem Van der Does
Professor of Psychology
Leiden University Medical Center