Effects of Melatonin on the incidence of Delirium

The effect of Melatonin on the incidence of Delirium in hospitalized patients in the Intensive Care Unit

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150928024236N5

Enrollment

140

Registered

2018-10-07

Start date

2016-07-22

Completion date

Unknown

Last updated

2018-11-05

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

Conditions

Delirium. Other delirium

Interventions

Intervention 1: Intervention : Melatonin (Nature Made), tablet 3 mg, once daily (21:00 AM), orally for 7 consecutive days. Intervention 2: Control group: Placebo (consists of tricalcium phosphate, mag

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients age 30 and over with less than 24 hours duration from ICU admission Patients with Glasgow coma scale (GCS) > 8 Patients without mechanical ventilation Patients with informed consent

Exclusion criteria

Exclusion criteria: History of delirium or mood disorder before ICU admission Trauma and intracranial hemorrhage Receive medications such as Benzodiazepines History of epilepsy, seizure attack

Design outcomes

Primary

Measure	Time frame
Delirium. Timepoint: Daily (from initial of study for 7 days). Method of measurement: Questionnaire of CAM-ICU.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Hosseini

Yazd University of Medical Sciences

hosseini.k.f@gmail.com+98 35 3263 2005

Outcome results

None listed

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