The effectiveness of agomelatine on rate of delirium

A clinical trial to compare the effectiveness of agomelatine with placebo on rate of delirium in patients admitted to the cardiac surgery intensive care unit

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220508054780N4

Enrollment

Registered

2024-01-21

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Delirium. Delirium not superimposed on dementia, so described

Interventions

Intervention 1: Intervention group: The intervention group will receive 25 mg agomelatine (Tadbir Kalaye Jam, Tehran, Iran) orally 18 hours after hospitalization. This will be administered daily for a

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Aged between 18 and 75 years Staying more than 72 hours in the intensive care unit Receiving medication following admission to hospital from the first day Having stable hemodynamics based on confusion assessment method for the ICU (CAM-ICU)

Exclusion criteria

Exclusion criteria: Patients who were treated with agomelatine before ICU admission Having agomelatine allergies Pregnant and breastfeeding women Having Alzheimer Having hepatic dysfunction Having high APACHE II score The patient dies in the first 3 days of admission Patients who require of only parenteral nutrition Using strong 1A2 inhibitors (ciprofloxacin, fluvoxamine)

Design outcomes

Primary

Measure	Time frame
Incidence and severity of delirium. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Confusion Assessment Method for the ICU (CAM-ICU).;Sleep quality. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Pittsburgh Sleep Quality Index (PSQI).;Pain management. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Critical-care pain observation tool (CPOT).	—

Measure

Time frame

Incidence and severity of delirium. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Confusion Assessment Method for the ICU (CAM-ICU).;Sleep quality. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Pittsburgh Sleep Quality Index (PSQI).;Pain management. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Critical-care pain observation tool (CPOT).

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Secondary

Measure	Time frame
Duration of hospital care unit stays. Timepoint: After intervention. Method of measurement: Based on the number of days of hospitalization.;Number of days dependent on ventilator. Timepoint: After intervention. Method of measurement: The number of days the ventilator is used for the patient.;Mortality rate. Timepoint: After intervention. Method of measurement: Based on acute physiology and chronic health evaluation score (APACHE) II score.	—

Measure

Time frame

Duration of hospital care unit stays. Timepoint: After intervention. Method of measurement: Based on the number of days of hospitalization.;Number of days dependent on ventilator. Timepoint: After intervention. Method of measurement: The number of days the ventilator is used for the patient.;Mortality rate. Timepoint: After intervention. Method of measurement: Based on acute physiology and chronic health evaluation score (APACHE) II score.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBenyamin Fazli

Mashhad University of Medical Sciences

fazlib@mums.ac.ir+98 51 3802 2711

Outcome results

None listed

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