Zolpidem trial in traumatic brain injury

Evaluation of zolpidem effect on level of conciousness and regional brain perfusion in patients with vegetative state due to trauma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130310012776N5

Enrollment

Registered

2019-03-10

Start date

2018-05-22

Completion date

Unknown

Last updated

2019-03-25

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

Conditions

Vegetative life after traumatic brain injury. Intracranial injury

Interventions

Intervention group: Zolpidem 10 mg PO BID for 2 weeks.

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: being in vegetative state due to trauma for more than 4-8 months, in a medically stable condition no severe complications or other comorbidities in addition to brain damage good nutritional status (BMI>18 kg/m2) accepting to participate in the study by patients' family or guardian

Exclusion criteria

Exclusion criteria: Allergic reaction to zolpidem Indication for any additional surgical or medical intervention during zolpidem treatment poor cooperation for SPECT imaging

Design outcomes

Primary

Measure	Time frame
Motor part of GCS. Timepoint: at biggining and two weeks later after treatment. Method of measurement: physical exam by physician.;Glascow outcome scale extended (GOSE). Timepoint: at biggining and two weeks later after treatment. Method of measurement: physical exam by physician.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contacthosseinali khalili

Shiraz University of Medical Sciences

khalili_h@sums.ac.ir+98 71 3625 4206

Outcome results

None listed

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