Health Condition 1: null- Chronic Anxiety and Insomnia
Conditions
Interventions
Intervention1: Etizolam CR 1.5mg: 1.5 mg
Control Intervention1: Etizolam: 0.5mg
Sponsors
Precise Biopharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ■ All patients with duly filled and signed in ICFs [Informed Consent Forms] ■ Ages: > 18 years and ■ 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
Exclusion criteria
Exclusion criteria: ■ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Change in mean latency in persistent sleep [LPS] measured by polysomnography (PSG) recording in the hospital between day 0 and day 7.Timepoint: day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To be assessed by polysomnography to record change between day 0 and day 7. ? Total Sleep Time [TST] ? Sleep Efficiency. ? Wake Time after Persistent Sleep Onset. ? Number of Awakenings after Persistent Sleep. To be assessed by subject sleep diary and sleep questionnaire ? Subjective Sleep Latency. ? Subjective Total Sleep ? Subjective Sleep Quality. ? Subjective Wake Time after Sleep Onset. ? Subjective Number of Awakenings. ? Subjective Ease of Falling Back to Sleep after Awakening. ? Stage 1 Nonrapid Eye Movement (NREM) Sleep ? Stage 2 Nonrapid Eye Movement (NREM) Sleep ? Stage 3/4 Nonrapid Eye Movement (NREM) Sleep ? Latency to Rapid Eye Movement (REM) Sleep ? Percentage of Total Sleep Time in REM Sleep Timepoint: day 7 | — |
Countries
India
Contacts
Public ContactDr. Kavan P. Lakdawala
Outcome results
None listed