Evaluation of the effect of Trazodone in hospitalized patients with MS

Phase 3

Recruiting

• Conditions: MS.; Multiple sclerosis

• Registration Number: IRCT20210707051810N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.