Magnetic Resonance Spectroscopy and Medication Response: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.
研究概览
简要总结
We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed patients.
详细描述
The primary objective of this study is to demonstrate that it is feasible to image paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed patients.
The longer-term goal is to determine the relationship between clinically administered doses of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) (antidepressants), the amount of drug in the body via blood level, the concentrations of the drug achieved in brain measured via MRS, and genetics.
It has been previously reported that individuals taking 20mg of paroxetine daily had brain paroxetine [(Paxil) levels via MRS ranging from 2-13 micromolar. Similar or slightly higher ranges of brain drug concentrations have been reported for fluoxetine and fluvoxamine.
Since not all depressed patients respond to medications, one reason may be the amount of medication that crosses the blood-brain barrier. This may be influenced by genetic information. We want to examine these issues on a larger scale, but first we need to demonstrate that we can indeed determine paroxetine [(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)] levels via MRS.
Intended results analysis could not be conducted because a reliably sensitive spectroscopic method could not be developed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM diagnosis of Major Depressive Disorder
- •Taking paroxetine [(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)]for at least 6 weeks
- •Between 21 - 75 years of age.
- •Taking a stable dose of paroxetine [(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)] for at least the 2 weeks prior to the imaging session
- •Healthy controls:
- •Between 21 - 75 years of age.
- •Have a 21-item HAM-D score of less than or equal to
- •No current, or history of any Axis I disorder.
- •Identify exclusion criteria.
- •Exclusion criteria are as follows:
- •Contraindications for an MRI exam. These includes biomedical devices such as pacemakers, aneurysm clips, prostheses, and other metallic objects embedded in the body such as bullets, buckshot, shrapnel, and any metal fragments from working around metal.
- •Current pregnancy or lactation.
- •Patients with claustrophobia.
- •History, or current Axis I or Axis II disorders
- •Active unstable medical problems, as confirmed by screening procedures
- •Diagnosed with any autoimmune disease, (e.g., rheumatoid arthritis, Lupus, MLS).
- •Chronic use of steroids or opiates.
- •Positive urine toxicology screen for illicit substances of abuse.
排除标准
- 未提供
结局指标
主要结局
Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.
时间窗: Within 7 Days following MRS
Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed participants.
次要结局
未报告次要终点
研究者
Alan Schatzberg
Professor, Department of Psychiatry and Behavioral Sciences
Stanford University