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Studying the effect of agomelatine in delirium

Effect of Oral Agomelatine on Delirium Incidence in ICU Patients : A Randomized, Triple-Blind Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250411065288N1
Enrollment
33
Registered
2025-06-16
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Delirium. Delirium due to known physiological condition

Interventions

Intervention 1: Intervention group: Oral agomelatine is prescribed at a dose of 25 mg every night at 6 p.m. and is manufactured by Tadbir Kalay Jam Company (Tagajeh). Intervention 2: Control group: Co

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age: Individuals over 18 years of age admitted to the intensive care unit Informed consent Oral route: Patients are able to receive medication orally or via an orogastric/nasogastric tube.

Exclusion criteria

Exclusion criteria: Severe hepatic dysfunction: or elevation of transaminases to more than three times the upper limit of normal Contraindications to agomelatine: Known hypersensitivity or adverse reactions to agomelatine. Severe cognitive impairment: Patients with advanced dementia or other severe cognitive impairment that make meaningful assessment of delirium impossible. Drug interactions: Taking medications that may severely interact with agomelatine (such as cytochrome P450 1A2 inhibitors such as fluvoxamine) Pregnancy or lactation: Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Incidence of delirium. Timepoint: To investigate the incidence of delirium in patients admitted to the intensive care unit, they were assessed upon entry into the study and then daily thereafter. Method of measurement: CAM ICU, Richmond sedation scale.

Secondary

MeasureTime frame
Identifying a treatment method to reduce the incidence of delirium in patients admitted to the intensive care unit. Timepoint: It will be determined at the end of the study. Method of measurement: CAM ICU , richmond sedation scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Farrokhian

Shahid Beheshti University of Medical Sciences

a.farrokhian@sbmu.ac.ir+98 21 8820 0100

Outcome results

None listed

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