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the effect of melatonin for the management of delirium and agitation

Evaluation of the effect of melatonin for the management of delirium and agitation in patients with delirium receiving quetiapine in intensive care unit: a randomized-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150221021159N8
Enrollment
116
Registered
2021-12-11
Start date
2022-01-21
Completion date
Unknown
Last updated
2022-01-11

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

Conditions

Condition 1: Delirium. Condition 2: Agitation. Delirium due to known physiological condition Restlessness and agitation

Interventions

Intervention 1: Intervention group: In addition to the essential and standard treatment for delirium, two tablets of Melatonin 3 mg (Razak pharmaceutical company), once daily at 9 P.M., will be admini

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years or older Hospitalization in the intensive care unit with delirium receiving quetiapine Normal gastrointestinal function to receive medication by the mouth or other enteral routes Capability to follow the patient for at least 7 days Full consent and acceptance of the patient or their legal guardian to recruit in the study

Exclusion criteria

Exclusion criteria: Patients with GCS= 8 History of severe melatonin allergy History of epilepsy or seizures Chronic heart failure ( New York Heart Association classification III/IV ) The patient's Richmond Agitation-Sedation Scale (RASS) is about -4 or -5 Head trauma History of delirium or mood changes before admission to the ICU

Design outcomes

Primary

MeasureTime frame
Improvement of patient's delirium. Timepoint: Daily from the beginning of the study. Method of measurement: CAM-ICU questionnaire for delirium.;Agitation. Timepoint: Daily from the beginning of the study. Method of measurement: Richmond agitation sedation scale score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadi Farsaei

Esfahan University of Medical Sciences

Farsaei@pharm.mui.ac.ir+98 31 3792 7071

Outcome results

None listed

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