Protocol summary

Study aim
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
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Sepehr Mazloomi Koohbanani
Street address
Razi psychiatric hospital, Rastegar Blvd, shahr_e_rey, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1867612016
Phone
+98 21 3340 1226
Email
sepehr.mk@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Reza Khorram Khorshid
Street address
University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
Hrkhkh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sepehr Mazloomi Koohbanani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2832
Email
sep.mazloomi@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sepehr Mazloomi Koohbanani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2832
Email
sep.mazloomi@uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sepehr Mazloomi Koohbanani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
University of social welfare and rehabilitation sciencess, Koodakyar st, Daneshjoo blvd, Evin st, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2832
Email
sep.mazloomi@uswr.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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