Effect of mirtazapine on pruritus in dialysis patients

Phase 2

Recruiting

• Conditions: remic pruritus.; Pruritus, unspecified; L29.9

• Registration Number: IRCT20120314009297N9
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age older than 18 years
Hemodialysis for at least 3 months and having itch despite the adequacy of hemodialysis (Kt/V > 1.2)
5D-itch score more than 5
PSQI score equal and above 5

Exclusion Criteria

Anemia ( Hemoglobin less than 7 g/dL)
Hyperparathyroidism ( iPTH > 600 )
Phosphorus level higher than 6 mg/dL and calcium higher than 10.5 mg/dL, or calcium multiplied by phosphorus higher than 60
Chronic skin diseases with itching which not related to uremia caused by kidney failure, such as psoriasis, dermatitis, and lichen planus.
Chronic liver failure or high bilirubin level (1.5 times higher than the upper limit of normal) , and ALT, AST more than 5 times higher than the upper limit of normal.
Untreated hypothyroidism
Patients with psychiatric disorders, such as bipolar disorder, mental retardation, cognitive-functional disorder, or use of any psychotropic medication during the past month.
History of suicide or patients with suicidal ideation
Inability to receive oral medication
Use of corticosteroids and opium
Pregnancy and lactation
History of allergy to mirtazapine
Receiving medications that used for sleep disorders treatment within 1 month before entering the study (such as tricyclic antidepressants, atypical antidepressants, benzodiazepines, antihistamines, anticholinergics, and barbiturates)
No interest to participate in the study or continue to treatment
Any complications leading to intolerance and discontinuation of treatment with studied drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of itch Intensity using 5D-itch criteria. Timepoint: Baseline and the end of second, third and fourth weeks of starting the drug. Method of measurement: 5D-itch checklist.

Secondary Outcome Measures

Name	Time	Method
Sleep quality changes based on the PSQI criterion. Timepoint: Baseline and the end of second, third and fourth weeks of starting the drug. Method of measurement: PSQI checklist.;Evaluation safety of the studied drugs. Timepoint: The end of the first, second and third weeks of starting the drug. Method of measurement: ASEC checklist.