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IRCT20191218045795N7 IRCT 2023-02-25 Sanandaj University of Medical Sciences The effectiveness of cyproheptadine in the treatment of acute akathisia caused by neuroleptics The effectiveness of cyproheptadine in the treatment of acute akathisia caused by neuroleptics 2023-03-21 anticipated 50 Complete https://irct.ir/trial/63067 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 4 - block allocationrandom Patients are placed in two groups A and B by the assistant using the randomized block method. For this randomization, pre-prepared cans and medicines are made by the pharmacist and based on the patients in the order provided by the statistical consultant. The patient and the outcome researcher are unaware of which of the two groups is receiving the medication or placebo. Random allocation method: Individuals are assigned to the intervention and control groups using the method of forming 4 random blocks as follows. AABB, ABAB, BBAA, BABA A: Intervention Group B: Control Group Up to 48 people are randomized using the formation of 4 random blocks and random selection from the sequence of these blocks. For the remaining two people, each of them will be placed in one of the intervention and control groups using the lottery method, Blinding description: Placebo was made of inert substances designed to have no effect. In this study, except for the pharmacist who prepared the medication and placebo, all the other people including psychiatrists, patients, and researchers were blind to the study groups. 3 Akathisia. Intervention 1: Intervention group: The intervention in this study is Cyproheptadine. First, Cyproheptadine powder (manufactured by Tekaje-Iran ) which is prepared by a pharmacologist, is poured into empty capsules in the amount of 4 mg with empty scales. Cyproheptadine is easily poured from The gastrointestinal tract is absorbed and reaches the maximum blood level within two hours. Extensively metabolized in the liver, the most important biotransformation pathways of this drug are demethylation and oxidation. The capsules are then given to the patients in the intervention group by a trained nurse for 4 days at 9 pm. Intervention 2: Control group: Placebo is prepared based on the color of the requested powder (including flour, starch and pigment) and in the amount of 15 mg in the same capsules where the drug was poured, and it is completely the same shape, color and smell of Cyproheptadine. It also has no effect on acacia. Yes - There is a plan to make this available What will be shared: Participant individual data When: 6 months after publication To whom: People working in academic institutions Conditions: Researcher working on academic institution Where to obtain: Nshamsalizadeh@yahoo.com How to obtain: The application must be sent by the applicant to the research vice-chancellor of the University of Medical Sciences, if approved by the relevant vice-chancellor, the files will be sent via email. Comments:
public Narges Shamsalizadeh
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
Sanandaj Iran (Islamic Republic of) 6617978743 +98 87 3366 4957 nshamsalizadeh@yahoo.com Sanandaj University of Medical Sciences scientific Narges Shamsalizadeh
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
Sanandaj Iran (Islamic Republic of) 6617978743 +98 87 3366 4957 Nshamsalizadeh@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Get antipsychotic A minimum score of 2 on the akathisia scale BARS 20 years 65 years Both Receiving beta blocker, mianserin, cyproheptadine, vitamin B6 Suiccidal thoughtsevere Severe akathisia (score higher than 5 in BARS) G25.71 Drug induced akathisia Treatment - Drugs Placebo Intervention group: The intervention in this study is Cyproheptadine. First, Cyproheptadine powder (manufactured by Tekaje-Iran ) which is prepared by a pharmacologist, is poured into empty capsules in the amount of 4 mg with empty scales. Cyproheptadine is easily poured from The gastrointestinal tract is absorbed and reaches the maximum blood level within two hours. Extensively metabolized in the liver, the most important biotransformation pathways of this drug are demethylation and oxidation. The capsules are then given to the patients in the intervention group by a trained nurse for 4 days at 9 pm. Control group: Placebo is prepared based on the color of the requested powder (including flour, starch and pigment) and in the amount of 15 mg in the same capsules where the drug was poured, and it is completely the same shape, color and smell of Cyproheptadine. It also has no effect on acacia. BARS akathisia score. Timepoint: At the beginning of the study (before the start of the intervention) and 5 days after the start of cyproheptadine. Method of measurement: BARS akathisia questionaire. Sanandaj University of Medical Sciences Approved 2022-11-08 Ethics Committee of Kurdistan University of Medical Sciences No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)