Phase 3 placebo-controlled, double-blind study of MK-4305 (suvorexant) in Japanese participants at high risk of delirium (085 study)
- Conditions
- Delirium
- Registration Number
- JPRN-jRCT2031200149
- Lead Sponsor
- Tanaka Yoshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
Is hospitalized for (1) acute disease with severe disease state or decreased daily living function or (2) elective surgery requiring general anesthesia scheduled on the day after or 2 days after admission/Day 1
- Has (1) mild cognitive impairment or mild dementia and/or (2) a history of delirium in any prior hospitalization
- Requires hospitalization (1) for 6 days for acute disease with treatment starting on the day of admission, or 7 days for acute disease with treatment starting the day after admission, OR (2) for 6 days for elective surgery scheduled the day after admission, or for 7 days for elective surgery scheduled 2 days after admission
- Is able to take study medications orally
- Has moderate or severe dementia
- Has a history of epilepsy or Parkinson's disease
- Currently uses psychotropic agents or has a mental condition
- Has a history of drug or alcohol abuse in the 5 years prior to start of study or has alcoholic disease
- Has a history of narcolepsy or cataplexy
- Has used hypnotics, antipsychotics, mood stabilizers, antidepressants, anxiolytics, psychostimulants, anticonvulsants or tiapride within 2 weeks prior to randomization
- Has delirium as assessed by DSM-5 or DRS-R-98 (total score =>14.5) before the first dose of study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method