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IRCT20120314009297N9 IRCT 2024-02-24 Mazandaran University of Medical Sciences Effect of mirtazapine on pruritus in dialysis patients Comparison of the efficacy and safety of mirtazapine and hydroxyzine in the treatment of uremic pruritus in hemodialysis patients: A randomized, double-blind controlled clinical trial 2023-10-23 anticipated 60 Complete https://irct.ir/trial/72945 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are placed in the intervention and control groups ( with 1:1 ratio) based on a random block. The supervisor will perform randomization by using a random numbers table and assignment of 4-digit codes in both groups. The drugs and placebo will be placed in separate packages. The patient, the physician and the student (Clinical pharmacy resident) will be blind in this study. At the end of the study, the codes will be broken for statistical analysis, Blinding description: Preparation of placebo from the manufacturing company or preparation of similar capsules of drug and placebo by someone outside the study. The attending physician, patient and evaluator student will be blinded. 2-3 Uremic pruritus. Intervention 1: Intervention group: Mirtazapine tablets 7.5 mg (half a 15 mg tablet) in the first two nights and 15 mg (a whole tablet) from the third night at bedtime, along with hydroxyzine placebo for 2 weeks. Intervention 2: Control group: Hydroxyzine tablets 12.5 mg (half a 25 mg tablet) in the first two nights and 25 mg (a whole tablet) from the third night at bedtime, along with Mirtazapine placebo for 2 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet - the release schedule is not clear yet
public Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences scientific Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 L29.9 Pruritus, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Mirtazapine tablets 7.5 mg (half a 15 mg tablet) in the first two nights and 15 mg (a whole tablet) from the third night at bedtime, along with hydroxyzine placebo for 2 weeks Control group: Hydroxyzine tablets 12.5 mg (half a 25 mg tablet) in the first two nights and 25 mg (a whole tablet) from the third night at bedtime, along with Mirtazapine placebo for 2 weeks 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. 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. Mazandaran University of Medical Sciences Approved 2023-10-25 Ethics committee of Mazandaran University of Medical Sciences Building No 2, Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)