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Edaravone in delirium

Investigation of the clinical effectiveness of the injectable drug Edaravone in the improvement and treatment of delirium conditions in patients with dementia compared to the control group : a randomized clinical study comparing with a double-blind control group

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250728066664N1
Enrollment
41
Registered
2025-08-25
Start date
2025-08-23
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium Superimposed on Dementia. Delirium due to known physiological condition

Interventions

Intervention 1: Intervention group: Edaravone, IV infusion, 60mg in 200cc of normal saline, daily infusion for 5 days. Intervention 2: Control group: Delirious patients according to entry criteria, 20

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: acute delirious state a prior history of dementia or current diagnosis of dementia age>65 the patient's cooperation and the patient's or the caregiver's consent

Exclusion criteria

Exclusion criteria: the presence of other cognition-altering diseases or syndromes: depression, Parkinson, Huntington, normal pressure hydrocephalus, seizure, a prior history of moderate to severe head traumas, acute cerebral infarction, chronic psychiatric conditions auditory, visual or articulatory problems causing a misunderstanding of communication an underlying malignancy and life expectancy less than 6 months renal failure or creatinine clearance rate less than 5 liver failure and liver enzyme levels more than 2 times the normal range a positive screening test for HIV or hepatitis B or C chronic cardiovascular or respiratory disease an active infection prior use of cimetidine, diclofenac or probenecid substance or alcohol abuse in the prior 3 months

Design outcomes

Primary

MeasureTime frame
Confusion Assessment Method Score. Timepoint: Before the treatment, 5 days after the treatment, 30 days after the treatment. Method of measurement: Confusion Assessment Method.

Secondary

MeasureTime frame
Delirium Rating Scale Score. Timepoint: Before the treatment, 5 days after the treatment, 30 days after the treatment. Method of measurement: Delirium Rating Scale.;Mini Mental State Examination Score. Timepoint: Before the treatment, 5 days after the treatment, 30 days after the treatment. Method of measurement: Mini Mental State Examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNika Keshtkaran

Tehran University of Medical Sciences

keshtkarannika@gmail.com+98 21 8810 0040

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026