Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
Sleep Initiation and Maintenance Disorders
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders
Eligibility Criteria
Inclusion_Criteria: Patients will be eligible for enrollment of this study if they meet all of the following criteria: Willing and able to provide written informed consent Male or female, aged 18 - 65 (including 18 and 65) Diagnosed as insomnia by the criteria of CCMD-3: Exclusion_Criteria: Who received any central nervous system drugs within one week before visit 2(baseline) Continuous use of hypnotic agents for more than 3 months recently History of inefficiency with benzodiazepine-type hypnotics Who have a history of obvious hypersensitivity Hamilton Depression Rating Scale (HAMD)18 Who was diagnosed with other mental illness With serious diseases of heart, liver and kidney, etc Who had sleep apnoea syndrome Who had epileptic seizures within one year With angle closure glaucoma that is acute or easy to occurred Whose AST or ALT values are 2 times of normal upper limit Whose Cr or BUN values are 2 times of normal upper limit Who are known to be prone to the abuse of alcohol (i.e. history of evidence of acute or chronic abuse), or any other addictive agents Who is participating in other clinical trial, or have participated in a clinical study of any other drug in one month prior to visit 2 (baseline). In addition, patients who has been randomized in this trial and then withdrew can not be enrolled again. All pregnant, lactational women and women who have the plan of pregnancy. Who are unwilling to or not able to complete the whole clinical trial Other patients who are unsuitable to be included in the trial judged by investigator
Sites / Locations
- Third Hospital of Beijing Hospital
- Beijing Anding Hospital
- Beijing Hospital
- Peking Union Medical College Hospital
- Guanzhou Psychiatric Hospital
- Shanghai Mental Health Center
- Hu Shan Hospital, Fu Dan University
- Tongji Hospital, Tongji University