Preventive effect of active Potocol-Based Pharmacotherapy Management for delirium

JRCT ID: jRCTs051220122

Registered date:25/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Delirium
• Date of first enrollment: 25/11/2022
• Target sample size: 105
• Study type: Interventional

Intervention(s)

<Active Protocol-Based Pharmacotherapy Management group>
(When oral administration is impossible) Blonanserin; apply 8mg to the skin daily from 19:00 to 6:00 the next morning for 3 days. If insomnia does not improve, increase the dose to 40mg the next day or later.
(When oral administration is possible) Ramelteon(8mg) and Lemborexant (5mg) orally daily at 19:00 for 3 days. If insomnia does not improve, add 5mg of lemborexant.
<Passive Protocol-Based Pharmacotherapy Management group>
(When oral administration is impossible) No medication
(When oral administration is possible)
If insomnia is observed, ramelteon (8 mg) and lemborexant (5 mg) are orally administered. From the day after insomnia is observed, ramelteon (8 mg) will be administered regularly before sleep, and lemborexant (5 mg) will be administered only if insomnia is observed. Additional administration of lemborexant (5 mg) is possible.

Outcome(s)

• Primary Outcome: Incidence of delirium diagnosed with DSM-5 within 3 days of hospitalization
• Secondary Outcome: Cumulative incidence of delirium within 3 days of hospitalization, Incidence of delirium diagnosed with DSM-5 by study drug within 3 days of hospitalization, Total score (worst value for 3 days) of DRS-R98-J (Japanese version of the delirium Rating Scale, Revised-98), Severity score (worst value for 3 days) of DRS-R98-J, Score for item 1 of DRS-R98-J, "Sleep-wake cycle disturbance", Total dose of rescue drug hydroxyzine, Incidence of restlessness within 3 days of hospitalization, Incidence of restlessness and agitation associated with dementia within 3 days of hospitalization

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who are admitted to the general ward of the department of primary care and emergency medicine from the emergency room between 8:30 and 17:00.
2) One or more of the following six risk factors for developing delirium: central nervous system disease, cognitive dysfunction, history of high alcohol intake, history of delirium, use of drugs at risk of delirium, Post-surgery or scheduled surgery requiring general anesthesia.
3) Patients over 65 years old.

Exclude criteria

1) Patients with schizophrenia
2) Patients taking antipsychotics.
3) Patients who cannot be hospitalized for more than48 hours.
4) Patients taking benzodiazepines prescribed by a psychiatrist or psychosomatic physician
5) Patients taking CYP3A4 inhibitors (itraconazole, clarithromycin, erythromycin, fluconazole, verapamil, HIV protease inhibitor, etc.)
6) Patients taking Ramelteon or lemborexant
7) Blonanserin patch is applied
8) Patients with severe liver dysfunction
9) Patients with severe disturbance of consciousness
10) Sedatives are used before the start of the study
11) Patients with drug abuse

Related Information

• Primary Sponsor: Ohtsuru Shigeru