The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Co-morbid Anxiety and Insomnia: A Proton MRS Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.
研究概览
简要总结
The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression, anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate, glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis was that levels of glutamine and glutamate will be increased in women receiving eszopiclone compared to those receiving placebo. The antidepressant effect of the medication combination and its effect on sleep status was also assessed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18 to 55 years and regularly menstruating.
- •Meets DSM-IV criteria for unipolar major depression.
- •Insomnia severity index score >
- •Hamilton Anxiety scale score >
- •Hamilton Depression scale score >
- •Capable of providing informed consent.
- •Has an established residence and phone.
排除标准
- •Meets DSM-IV criteria for schizophrenia, schizoaffective disorder or other axis I or II diagnosis except co-morbid anxiety disorder and insomnia.
- •Actively abusing substances or alcohol; or has met DSM-IV criteria for substance dependence in the past month.
- •Pregnancy.
- •Use of benzodiazepines or other sedative-hypnotics, beta blockers, calcium channel blockers, antidepressants, antipsychotic medications, lithium or other medication which in the opinion of the investigator could alter glutamate or GABA activity in the brain.
- •A medical condition, which in the opinion of the investigator could possibly affect the individual's brain levels of Glu and GABA.
- •Participation in a research protocol that included administration of medication within the past 3 months.
- •Cigarette smoking.
- •Subject has known allergic sensitivity to any of the study to escitalopram, eszopiclone or zopiclone.
- •Clinically significant suicidal ideation or risk of suicide as evidenced by formulation of a plan or steps taken to act on those feelings.
- •History of clinically significant hepatic impairment.
- •Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.
研究组 & 干预措施
Eszopiclone
Lexapro for 10 weeks together with eszopiclone.
干预措施: Eszopiclone (Drug)
Placebo
Lexapro for 10 weeks together with placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.
时间窗: baseline and 1 week
Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.
Change in Thalamic Glutamine From Baseline to Week 1
时间窗: baseline and 1 week
Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.
次要结局
- Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1(baseline and 1 week)
- Change in Thalamic Glutamate From Baseline to Week 1(baseline and 1 week)
- Change in Anterior Cingulate Cortex GABA From Baseline to Week 1(baseline and 1 week)
- Change in Thalamic GABA From Baseline to Week 1(baseline and 1 week)
- Change in Hamilton Depression Rating Scale Score From Baseline to Week 10(baseline and 10 weeks)
- Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10(baseline and 10 weeks)
- Change in Insomnia Severity Index Score From Baseline to Week 10(baseline and 10 weeks)