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Evaluation of the effect of Trazodone in hospitalized patients with MS

Comparison of the effectiveness of Trazodone with placebo in preventing acute sleep disturbances caused by corticosteroid pulse in hospitalized patients with MS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210707051810N1
Enrollment
48
Registered
2021-09-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2021-11-01

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

Conditions

MS. Multiple sclerosis

Interventions

Intervention 1: Intervention group: Patients in this group use 50 mg trazodone tablets of Tehran Shimi Company every night at 9 o'clock from the first day of hospitalization until the day of discharge

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with relapsing-remitting MS who are between 18 and 65 years old and hospitalized for treatment with corticosteroid pulse. Hospitalized patients who are candidates for corticosteroid pulse at the rate of 1 gram per day for 3 to 5 days.

Exclusion criteria

Exclusion criteria: Receiving other sleeping pills such as Barbiturates, Benzodiazepines, Doxepin, Melatonin and Zolpidem in the last 2 weeks Having Primary Insomnia Trazodone use in the last 2 weeks Taking Monoamine oxidase inhibitor drugs in the last 2 weeks History of hypersensitivity reaction to Trazodone or any components in the formulation Severe chronic renal failure (Creatinine clearance less than 30 ml/min) and liver failure Pregnancy and lactation Patients receiving concomitant Intravenous immunoglobulin or plasma exchange other than Corticosteroid pulse

Design outcomes

Primary

MeasureTime frame
Insomnia score in Verran and Snyder-Halpern questionnaire (VSH). Timepoint: Every day from the first day of hospitalization until the day of discharge (A total of 3 to 5 days). Method of measurement: VSH questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHooshyar Honarmand

Tehran University of Medical Sciences

Hooshyar1978@gmail.com+98 21 8832 2025

Outcome results

None listed

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