Phase 3 placebo-controlled, double-blind study of MK-4305 (suvorexant) in Japanese participants at high risk of delirium (085 study)

JRCT ID: jRCT2031200149

Registered date:13/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Delirium
• Date of first enrollment: 22/10/2020
• Target sample size: 200
• Study type: Interventional
• Intervention(s): MK-4305 15 mg, Placebo

Outcome(s)

Primary Outcome

Percentage of participants with delirium as assessed by diagnostic and statistical manual of mental disorders 5th edition (DSM-5) criteria

Number of participants who experience one or more adverse events (AEs)

Number of participants who discontinue study treatment due to an AE

Secondary Outcome

Maximum daily total score on Delirium Rating Scale-Revised-98 (DRS-R-98)

Percentage of participants with delirium as assessed by DRS-R-98

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT04571944