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IRCT20220103053615N1 IRCT 2022-04-18 University of social welfare and rehabilitation sciences Best Choice between aripiprazole and risperidone in methamphetamine psychosis Comparison of the effectiveness of aripiprazole and risperidone on the psychotic symptoms of methamphetamine use 2022-04-30 anticipated 64 Complete https://irct.ir/trial/61064 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We are going to divide samples into two (A) and (B) groups using block randomization of size 4. letters A and B would be used randomly to make 6 blocks of 4 letters and 6 blocks are going to be labeled with numbers 1 to 6. 16 times, random numbers from 1 to 6 are chosen and corresponding block of letters are written down in a row. For example if the first random number is 2 and second number is 5, letters in block no.2 are written down and letters in block no.5 are going to be written after (repeated up to 16 blocks) and a random row of letters A and B ( of size 64) is generated. Number for Place of letters in the row would be written on the sealed envelope and the letters would be placed inside. The envelopes with numbers coresponding to the number of the patients according to participation time, is opened by researcher and group of each participant is determined (A or B) when they roll into the study, Blinding description: this is a double blinded study. Both participants and researcher who is tasked with diagnosis and clinical evaluation, are unaware of the medication given to participants. shape, smell, color and taste of both medications are similar which are delivered by a nurse and researcher is invited by clinical care giver to perform the evaluation. 3 Metamphetamin induced psychotic disorder. Intervention 1: intervention group 1:taking Risperidone oral tablet, 2-8mg over 24 hours variable dosage decided by clinical care giver, daily, for at least a month and abidi pharma brand. Intervention 2: intervention group 2:taking Aripiprazole oral tablet, 5-20mg over 24 hours variable dosage decided by clinical care giver, daily, for at least a month and abidi pharma brand. 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 Further information is unavailable for now
public Sepehr Mazloomi Koohbanani
University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2832 sep.mazloomi@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Sepehr Mazloomi Koohbanani
University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2832 sep.mazloomi@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Men and women with written informed consent to enter the trial At least one Positive and Negative Syndrome Scale score equal or greater than 4 Methamphetamine use in less than 4 weeks leading to admition No other substance dependencies except for Tobacco diagnosis of Metamphetamin induced psychotic disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition 18 years 60 years Both Sever nonpsychiatric condition in which Risperidone or Aripiprazole are contraindicated Aripiprazole or Risperidone Allergies Active suicidal or homicidal thoughts Comorbid mood or anxiety disorders Pregnant or nursing women or high suspicion of pregnancy Psychiatric medication use in last 4 weeks other than Benzodiazepines F15.15 Other stimulant abuse with stimulant-induced psychotic disorder Treatment - Drugs Treatment - Drugs intervention group 1:taking Risperidone oral tablet, 2-8mg over 24 hours variable dosage decided by clinical care giver, daily, for at least a month and abidi pharma brand intervention group 2:taking Aripiprazole oral tablet, 5-20mg over 24 hours variable dosage decided by clinical care giver, daily, for at least a month and abidi pharma brand Score of Positive and Negative Syndrome Scale. Timepoint: Days: 0, 7, 28 after medication. Method of measurement: Positive and Negative Syndrome Scale. University of social welfare and rehabilitation sciences Approved 2022-03-09 Ethics committee of the University of University of social welfare and rehabilitation sciencess University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran Tehran Tehran Iran (Islamic Republic of)