Comparing effectiveness of aripiprazole and risperidone in methamphetamine induced psychosis
Design
A block Randomized using a block size of 4, double blinded, two arm parallel group, clinical trial wich is performed on 32 patients in each experimental group.
Settings and conduct
eligible patients Admitted in razi psychiatric hospital diagnosed with Metamphetamin induced psychosis, would be assessed by researcher made questionnaire, vital signs and positive and negative syndrome scale after informed consent and before medication.assessment will be repeated using vital signs and positive and negative syndrome scale 1 week after medication. assessments are going to be repeated again using positive and negative syndrome scale and vital signs and saint Hans rating scale 4weeks after medication. researcher and data gatherer and patients would be unaware of the medication type and physical features of two medication types are going to be similar.
Participants/Inclusion and exclusion criteria
inclusion criteria: informed consent to enter the trial, No other substance dependencies except for Tobacco, diagnosis of Metamphetamin induced psychotic disorder based on Diagnostic and Statistical Manual of Mental Disorders 5th Edition
exclusion criteria: major or urgent psychiatric or nonpsychiatric condition including allergies to Risperidone or Aripiprazole, Psychiatric medication use in last 4 weeks other than Benzodiazepines
Intervention groups
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
Main outcome variables
Score of positive and negative syndrom scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220103053615N1
Registration date:2022-04-18, 1401/01/29
Registration timing:prospective
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Sepehr Mazloomi Koohbanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6515 1703
Email address
sep.mazloomi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of aripiprazole and risperidone on the psychotic symptoms of methamphetamine use
Public title
Best Choice between aripiprazole and risperidone in methamphetamine psychosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the University of University of social welfare and rehabilitation sciencess
Street address
University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.USWR.REC.1400.342
Health conditions studied
1
Description of health condition studied
Metamphetamin induced psychotic disorder
ICD-10 code
F15.15
ICD-10 code description
Other stimulant abuse with stimulant-induced psychotic disorder
Primary outcomes
1
Description
Score of Positive and Negative Syndrome Scale
Timepoint
Days: 0, 7, 28 after medication
Method of measurement
Positive and Negative Syndrome Scale
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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