CTRI/2020/09/027541进行中（未招募）未知
A randomized, multi-centric, double-blind, placebo-controlled trial of SDA-217 as an add-ontherapy in patients of chronic insomnia
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Has had chronic insomnia for at least 3 months
- •2. Has Insomnia Severity Index (ISI) >14
- •3. Not improving with standard of care for
- •management of Insomnia (CBT ?I, psychotherapy,
- •behavioral therapy or single drug pharmacotherapy) for at least after 8 weeks of
- •4. should be following sleep hygiene principles
- •5. has given informed consent prior to any study
- •related procedure
排除标准
- •1. Patients of obstructive sleep apnea (OSA) with AHI or RDI index more than 15
- •2. Patients with major depressive disorder, severe psychosis, significant anxiety disorder and any other neurological diseases
- •3. The non ?ambulatory chronic insomnia patients with comorbidities of terminal ?stage illness such as cancer, HIV, ESRD or cardiovascular diseases etc.
- •4. Pregnant and breast ?feeding women (Females of
- •childbearing potential who are sexually active must agree to use adequate contraception)
- •5. Patients of shift workers and patients with irregular bed time habits (deviation of more than 4 hrs for more than 2 times a week)
- •6. Patients who are taking antidepressant drugs for more than 1 month (SSRIs eg. fluoxetine, paroxetine, sertraline, citalopram, escitalopram, fluvoxamine, monoamine oxidase
- •(MAO) inhibitors, venlafaxine and duloxetine etc)
- •7. Patients who are taking CNS stimulants (eg.
- •methylphenidate, amphetamine and derivatives, ephedrine and derivatives, cocaine), decongestants (e.g. pseudoephedrine, phenylephrine, phenylpropanolamine),
- •narcotic analgesics (eg. oxycodone, codeine, propoxyphene), cardiovascular (a ?receptor agonists and antagonists),diuretics and bronchodilators (theophylline, albuterol),
- •respiratory stimulants, over ?the ?counter and prescription stimulants
- •8. Patients who are currently taking sedating H1
- •antihistaminics, systemic steroids, antipsychotics, muscle relaxants, melatonin and all other drugs or supplements known to affect sleep/wake function
- •9. Patients who are taking any caffeinated drinks (caffeine >90 mg or tea and coffee more than 3 cups) after 4 pm
- •10. Patients with history of alcohol abuse within the past 3 months
- •11. Patients with history of drug abuse within the past 3 months
研究者
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