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.

Dr Mahesh Gowda0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年6月24日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 50

研究概览入排标准研究者记录与标识符相似试验

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. Male and female patients above 18 years of age.
•2. Patients with HAM A score of at least 18) with known history of insomnia (ISI =7) not on pharmacotherapy
•3. Patients on psychotropics, after a washout period equivalent to four half-lives of the drug 4. 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
•5. Patients willing to fill patient diaries, have good compliance, and willing to comply with the study procedure and requirements
•6. Patients with no mental disease and are not using psychoactive medications
•7. 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

•1. 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
•2. 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
•3. Patients taking sleep medications, psychotherapy or acupuncture for insomnia within a month prior to enrolment into the study
•4. Patients with a history of drug addiction, drug or alcohol abuse or likely to concomitantly consume alcoholic beverages more than 3 times/week
•5. Patients with a progressive medical illness (e.g., cancer, dementia) directly related to the onset and course of insomnia
•6. 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)
•7. Patients with an evidence of sleep-disordered breathing or sleep-related movement disorder
•8. Patients with nightshift work or irregular sleep schedule
•9. Patients participated in any investigational drug trial within 4 weeks prior to enrolment into the study
•10. Patients with hypersensitivity to zolpidem tartrate or any of the inactive ingredients
•11. Patients who are not willing to follow study procedures and have poor treatment compliance 12. Chronic user of benzodiazepines as this may cause tolerance to zolpidem
•13. Patients with any other conditions or diseases that investigator considers it as inappropriate to enter the study as per prescribing information.
•14. Female patients who are pregnant, lactating or intend to become pregnant during the study period

研究者

发起方

Dr Mahesh Gowda

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