Effect of Melatonin on the incidence of agitation and delirium

Effect of Melatonin on agitation and delirium in hospitalized patients with head trauma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014071016917N2

Enrollment

118

Registered

2014-07-20

Start date

2014-08-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Head injury. Other disorders of the nervous system

Interventions

Intervention 1: Intervention1:Melatonin 5mg oral dose every night at 9 pm upto 10 days. Intervention 2: Intervention 2:Synthetic oral placebo tablet.

Prevention

Intervention1:Melatonin 5mg oral dose every night at 9 pm upto 10 days

Intervention 2:Synthetic oral placebo tablet

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : Age 18-55 years; Glasgow Coma Score (GCS) more than 9 to less or equal to 13 Exclusion criteria: History of mental disorders;Psychotropic drug abuse; Organic brain disorder

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Delirium. Timepoint: Every 12 hours upto 10 days. Method of measurement: CAM-ICU.;Agitation. Timepoint: Every 12 hours to 10 days. Method of measurement: Richmond score.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli ashraf

Guilan University of Medical Sciences

arcguilan1392@gmail.com+98 13 1321 0434

Outcome results

None listed

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