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临床试验/NCT01216449
NCT01216449终止不适用

Pharmacodynamics of Intravenous Citalopram in the Elderly: a Functional Magnetic Resonance Imaging Analysis

Rotman Research Institute at Baycrest1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
29
试验地点
1
主要终点
BOLD fMRI Response

研究概览

简要总结

Antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs) are most commonly prescribed to treat depression and anxiety. How antidepressants work on the brain to alter mood and behaviour is not well understood. This study will use a brain scanning technique (functional magnetic resonance imaging) to examine how aging impacts brain activation during emotional tasks after the administration of intravenous (IV) citalopram (this is the only SSRI available in this form, and is well tolerated and safe in young and old adults). The investigators will further determine what role genetic differences play in this relationship. The investigators expect to see an increase in brain signal as the concentration of IV citalopram increases. However, the investigators propose that the brain signal in older adults will not be as strong as in younger adults. Furthermore, the investigators expect that participants genetically predisposed to have fewer serotonin transporters (the site of action of SSRIs) will show greater decreases in brain activation with citalopram.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male aged 60 or older (elderly group)
  • Male aged 20-40 (younger adult group)
  • English speaking
  • Right-handed
  • Non-smoker
  • Score of 27 or greater on the Mini Mental State Exam

排除标准

  • Unstable medical, cardiac, or neurological illness (including stroke, brain tumour, epilepsy, significant head injury, Alzheimer's, Parkinson's or Huntington's disease)
  • Laboratory results indicating unanticipated illness or intolerability of blood drawing procedures or of study drug
  • Current or lifetime Axis-I psychiatric diagnosis on the DSM-IV/SCID (i.e., Module A: Mood, Module F: Anxiety, Module B & C: Psychosis)
  • History of drug or alcohol abuse within one year, or lifetime history of alcohol or drug dependence (i.e., SCID Module E: Substance Abuse, or clinically significant urine toxicology screen)
  • History of non-tolerance to SSRI therapy; including history of SSRI-related syndrome of inappropriate antidiuretic hormone secretion (SIADH) or sinus bradycardia on ECG (less than 50 beats per minute)
  • Contraindication to MRI (as per MRI Contraindication Screening Form)

研究组 & 干预措施

Intravenous Citalopram

Experimental

干预措施: Intravenous Citalopram (Drug)

Normal Saline

Placebo Comparator

250mL of 0.9% Sodium Chloride Solution

干预措施: Normal Saline (Drug)

结局指标

主要结局

BOLD fMRI Response

时间窗: Visit 1, Visit 2

Changes in affect-related neuronal activation as measured by blood oxygenation level-dependent (BOLD) fMRI response to IV citalopram are the primary outcome measures. Imaging data will be compared between IV citalopram and placebo administration and young and old adults.

次要结局

  • Genetics and Cognitive/Emotional Change(Visit 1, Visit 2)

研究者

发起方
Rotman Research Institute at Baycrest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruce Pollock

VP Research

Centre for Addiction and Mental Health

研究点 (1)

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