Comparative study of the effects of trazodone, melatonin, and trazodone/melatonin in the treatment of sleep disorders after traumatic brain injury: A randomized clinical trial

A comparative study of the effect of trazodone, melatonin and trazodone/melatonine in the treatment of sleep disorders following traumatic brain injury

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241121063793N1

Enrollment

Registered

2024-12-28

Start date

2025-01-19

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Sleep disorders after a concussion. ?????? ????

Interventions

Intervention 1: First intervention group: Every night, two hours before bedtime, take 25-100 mg of trazodone. Intervention 2: Second intervention group: Every night, two hours before bed, take 3-5 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: GCS score (based on the GCS) between 3 and 12 Suffered from severe or moderate concussion

Exclusion criteria

Exclusion criteria: any sleep disorders, fatigue syndromes, or neurological conditions present before traumatic brain injury current night shift work recent use of sleep medications vegetative state significant cognitive impairment

Design outcomes

Primary

Measure	Time frame
Insomnia Severity. Timepoint: Start studying, one month later. Method of measurement: Insomnia Severity Index (ISI).	—

Secondary

Measure	Time frame
Daytime sleepiness. Timepoint: Start studying, one month later. Method of measurement: Epworth Sleepiness Scale (ESS).;Fatigue severity. Timepoint: Start studying, one month later. Method of measurement: Fatigue Severity Scale (FSS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saeed Qarooee Ahangar

Kermanshah University of Medical Sciences

saeedgharooee@gmail.com+98 83 3835 7663

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: May 22, 2026