The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Glutamate Levels
研究概览
简要总结
The purpose of this study is to determine whether vilazodone is more effective than citalopram for the treatment of anxious depression. We will use neuroimaging to see whether there are changes in the brains of patients receiving the drug vilazodone that are different from those of citalopram. These changes may show that vilazodone affects the brain differently than most other kinds of standard antidepressant medications.
详细描述
This study proposes to utilize recent advances in magnetic resonance spectroscopy (MRS) techniques that permit reliable measurement of Glu in humans (9) to examine whether Vilazodone and citalopram exert differential effects on Glutamatergic neurotransmission in the ACC of anxious unipolar depressed patients. Functional connectivity as measured by Blood Oxygen Level Dependent (BOLD) MRI will be assessed to determine the relationship between the change in connectivity and the change in Glu levels with treatment. We also propose to examine, in an exploratory fashion, the relative effect of the two drugs on BOLD activation in the insula cortex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18-50 years.
- •Meets DSM-IV criteria for unipolar major depression.
- •MADRS score >
- •Subject exhibits clinically significant anxiety and HAM-A score >
- •Capable of providing informed consent.
- •Has an established residence and phone.
排除标准
- •A clinically significant medical condition which could impact the response of the individual to antidepressant treatment (e.g. diabetes, cancer, lupus or other autoimmune illness). Stably treated hypothyroidism (TSH < 2) will be permitted.
- •Beta blockers, antidepressants, antipsychotics, lithium, antiepileptic medications, steroids (oral and inhaled), chronic use of nonsteroidal antinflamatory medications (infrequent sporadic use permitted), or other medications with the potential to interfere with the antidepressant effects of Vilazodone.
- •Pregnancy.
- •In women of childbearing potential an unwillingness to use reliable methods to prevent pregnancy.
- •History of manic or psychotic symptoms.
- •History of seizure or epilepsy.
- •History of alcohol or drug dependence and active use of substances in the past month.
- •Active alcohol or drug abuse.
- •Ingestion of 4 or more caffeinated beverages a day, on average.
研究组 & 干预措施
Vilazodone
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
干预措施: Vilazodone (Drug)
Citalopram
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks.
干预措施: Citalopram (Drug)
结局指标
主要结局
Glutamate Levels
时间窗: Week 0 and Week 4
Our hypothesis that Vilazodone will increase ACC glutamate levels more than Citalopram will be addressed using a repeated measures linear regression model with ACC glutamate level as the outcome and drug (Vilazodone or Citalopram) and drug x scan time (baseline or follow-up) interaction as predictors.
次要结局
- Functional Connectivity(Week 0 and Week 4)
研究者
Michael Henry
Medical Director, Bipolar Clinic
Massachusetts General Hospital