A Prospective, pilot, randomized, single-center, clinical study to evaluate theeffectiveness and safety of Zolpidem Tartrate combined with cognitive behavioral therapyverses cognitive behavioral therapy alone in patients with insomnia associated with comorbidanxiety.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To evaluate the effectiveness of zolpidem tartrate combined with cognitive behavioral therapy (CBT) versus CBT alone in terms of reduction in Insomnia Severity Index (ISI) total score from baseline to follow up visit and End of study visit in patients with insomnia associated with comorbid anxiety.
研究概览
简要总结
Insomnia is a disturbance of normal sleep patterns commonly characterized by difficulty in initiating sleep (sleep onset insomnia) and/or difficulty in maintaining sleep (sleep maintenance) and imposes a significant negative impact on patient’s quality of life(QOL). Insomnia is prevalent public health problem affecting large number of population all over the world on a situational, recurrent, or chronic basis. Despite its high prevalence, morbidity, and costs, insomnia often remains untreated; when treatment is initiated, it is often limited to self-help remedies (e.g., alcohol, over-the-counter drugs) of questionable efficacy and safety. Patients with insomnia generally have subsyndromal levels of physiological symptoms of anxiety, including tachycardia, trembling, sweating, dizziness, gastrointestinal distress. There is a symptomatic overlap between insomnia and anxiety, including agitation, irritability, loss of appetite, muscle tension and poor concentration. Hence, treatment of insomnia may reduce the levels of anxiety and increase patient QOL. In the current investigator initiated study, we plan to evaluate the effectiveness and safety of the combination of CBT and Zolpidem Tartrate (a nonbenzodiazepine hypnotic indicated for short term treatment of insomnia) against CBT alone in patients with insomnia associated with comorbid anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients above 18 years of age.
- •Patients with HAM A score of at least 18) with known history of insomnia (ISI ≥7) not on pharmacotherapy
- •Patients on psychotropics, after a washout period equivalent to four half-lives of the drug
- •The patient has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure
- •Patients willing to fill patient diaries, have good compliance, and willing to comply with the study procedure and requirements
- •Patients with no mental disease and are not using psychoactive medications
- •Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigator’s discretion, throughout the study.
- •Female of childbearing potential must have a negative pregnancy test and be non-lactating at screening visit.
排除标准
- •Patients with sleep disorder such as narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome or obstructive sleep apnea syndrome or with severe, life-threatening chronic sleep disorders, hepatic failure, thyroid dysfunction, cardiovascular diseases, myasthenia gravis, respiratory insufficiency, anaphylaxis and angioedema
- •Patients with severe psychiatric disorder or a history of major psychiatric disorder (e.g. depression, autism, suicide attempt, bipolar disorder, schizophrenia etc.) or psychomotor impairment
- •Patients taking sleep medications, psychotherapy or acupuncture for insomnia within a month prior to enrolment into the study
- •Patients with a history of drug addiction, drug or alcohol abuse or likely to concomitantly consume alcoholic beverages more than 3 times/week
- •Patients with a progressive medical illness (e.g., cancer, dementia) directly related to the onset and course of insomnia
- •Patients who take medications known to alter sleep (e.g., Alpha-blockers, Betablockers, Corticosteroids, SSRI antidepressants, ACE inhibitors, ARBs Cholinesterase inhibitors, Histamine 1 antagonists, Glucosamine/chondroitin, and Statins)
- •Patients with an evidence of sleep-disordered breathing or sleep-related movement disorder
- •Patients with nightshift work or irregular sleep schedule
- •Patients participated in any investigational drug trial within 4 weeks prior to enrolment into the study
- •Patients with hypersensitivity to zolpidem tartrate or any of the inactive ingredients
- •Patients who are not willing to follow study procedures and have poor treatment compliance
- •Chronic user of benzodiazepines as this may cause tolerance to zolpidem
- •Patients with any other conditions or diseases that investigator considers it as inappropriate to enter the study as per prescribing information.
- •Female patients who are pregnant, lactating or intend to become pregnant during the study period.
结局指标
主要结局
1. To evaluate the effectiveness of zolpidem tartrate combined with cognitive behavioral therapy (CBT) versus CBT alone in terms of reduction in Insomnia Severity Index (ISI) total score from baseline to follow up visit and End of study visit in patients with insomnia associated with comorbid anxiety.
时间窗: At baseline visit(Day 0),week-4 and week-8
次要结局
- 1. To compare the improvement in symptoms of anxiety from baseline to follow up visit and End of study visit in group A versus group B(2. To assess health-related quality of life (HRQOL) from baseline to follow up visit and End of study visit in group A versus group B)