A clinical trial to study the effects of Etizolam CR 1.5 mg Tablet in comparison with Etizolam 0.5 mg Tablet in Subjects with Chronic Anxiety and Insomnia
- Conditions
- Health Condition 1: null- Chronic Anxiety and Insomnia
- Registration Number
- CTRI/2011/091/000026
- Lead Sponsor
- Precise Biopharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
■All patients with duly filled and signed in ICFs [Informed Consent Forms]
■Ages: > 18 years and < 65 years
■Genders Eligible for Study: both
■Confirmed diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual for Mental Disorders-IV [DSM-IV-TR]) present at the time of evaluation for at least 3 months
■Subjects will be eligible to continue in the double-blind treatment phase if they have a mean LPS ≥20 minutes on the 2 nights of PSG monitoring, with an LPS of no less than 15 minutes on either night
■Patients unwilling to sign on ICF
■Patients having participated in any previous studies of Etizolam, or having taken any other investigational drug within 30 days,
■Patients having sleep schedule changes associated with shift work
■Medications or supplements known to affect sleep-wake function must not have been taken within 5 days or 5 half-lives of the start of the study.
■Patients with a history of sleep apnea, chronic obstructive pulmonary disease, seizures, anxiety, depression, schizophrenia, bipolar disorder, mental retardation, a cognitive disorder,
■Patients with history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic diseases (unless controlled with protocol-allowed medications)
■Patients with history of drug addiction or abuse within 12 months of the study.
■At screening, if patients have an apnea-hypopnea index >10 or a periodic leg movement arousal index >10.
■Active malignant disease or current cytostatic treatment
■Known severe renal insufficiency
■Liver disease expected to have any potential impact on survival, or elevated A ST or ALT > 2x upper limit of normal
■Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
■Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practicing or do not plan to continue practicing acceptable methods of birth control
■Patients with a history of chronic hepatitis B or C infection, HIV infection
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method