A New Biomarker-Based Approach Towards Developing Improved Treatment for Major Depressive Disorder (MDD) Based Upon Targeting Monoamine Oxidase A (MAO-A)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- MAO-A distribution volume with positron emission tomography
研究概览
简要总结
The investigators will be looking at MAO-A density before and after seven weeks of treatment with an antidepressant and dietary supplement. MAO-A is an enzyme that breaks down brain chemicals that regulate mood. MAO-A density is elevated in patients with major depressive episodes (MDE) secondary to major depressive disorder (MDD). Many remain treatment resistant with common antidepressant treatments and we think it may be due to poor targeting of brain pathologies. We want to test if adding a dietary supplement may normalize MAO-A.
详细描述
All subjects are getting the combined treatment of a selective serotonin reuptake inhibitor and the dietary supplement. There are two possible selective serotonin reuptake inhibitor treatments but the dietary supplement remains the same. No subjects are receiving the selective serotonin reuptake inhibitor alone and no subjects are receiving the dietary supplement alone. The dietary supplement is called n-acetylcysteine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of current major depressive episode and major depressive disorder
- •Hamilton Depression Rating Scale score of at least 20
排除标准
- •Comorbid axis I or II disorders
- •Antidepressant use in past 6 months
- •Current use of herbal remedies
- •Cigarette smoking
- •Drug or medication use within past 8 weeks
- •History of substance abuse/neurotoxin use
- •History of psychotic symptoms
- •History of CNS medical illness
- •Current substance use
- •Test positive on pregnancy test (women)
研究组 & 干预措施
Sertraline and n-acetylcysteine
Sertraline and n-acetylcysteine for seven weeks of treatment
干预措施: Sertraline (Drug)
Sertraline and n-acetylcysteine
Sertraline and n-acetylcysteine for seven weeks of treatment
干预措施: N-acetylcysteine (NAC) (Drug)
Citalopram and n-acetylcysteine
Citalopram and n-acetylcysteine for seven weeks of treatment
干预措施: Citalopram (Drug)
Citalopram and n-acetylcysteine
Citalopram and n-acetylcysteine for seven weeks of treatment
干预措施: N-acetylcysteine (NAC) (Drug)
Existing medication treatment & NAC
Existing depression medication treatment and n-acetylcysteine for seven weeks of treatment
干预措施: N-acetylcysteine (NAC) (Drug)
Existing medication treatment & NAC
Existing depression medication treatment and n-acetylcysteine for seven weeks of treatment
干预措施: Existing depression medication treatment (Drug)
结局指标
主要结局
MAO-A distribution volume with positron emission tomography
时间窗: before and after treatment, 7 weeks on average between measures
Treatment take 1 week for titration and 6 weeks at full dose=7weeks average
次要结局
- Blood markers of monoamine oxidase-A fragment level and glutathione level(before and after treatment, 7 weeks on average between measures)
- Hamilton Depression Rating Scale Score(before and after treatment, 7 weeks on average between measures)
- Magnetic Resonance Spectroscopy (n-acetylaspartate and glutathione levels)(before and after treatment, 7 weeks on average between measures)
研究者
Jeff Meyer
Canada Research Chair
Centre for Addiction and Mental Health