Comparison of the effectiveness and safety of Aripiprazole or Olanzapine in psychotic patients
Design
Population of the clinical trial includes patients with psychotic disorders selected based on inclusion criteria. A phase 2 non-randomized controlled trial is conducted monitoring 94 patients.
Settings and conduct
The study population includes psychotic patients randomly divided into two blind groups. First, BMI tests and other relevant tests are done. Second, the positive and negative symptoms questionnaire is administered to the blind groups. Then, either Olanzapine or Aripiprazole is prescribed for the patients. After one month, the patients will be re-examined and their height and weight are measured again to control BMI and then the side effect questionnaire is filled out. After two months, the patients are examined again and the process of the first month is repeated. finally, the information is analyzed using SPSS20 software.
Participants/Inclusion and exclusion criteria
Inclusion criteria :1) Diagnosing psychotic disorders through clinical interview and DSM5 and ICSDIII criteria 2) Prescribing Aripiprazole or Olanzapine as a treatment strategy 3) Patients aged 18،64 years. Exclusion criteria include: 1) People taking other medications such as sleeping pills with Aripiprazole or Olanzapine 2) Patients with dependence on or abuse of Aripiprazole or Olanzapine 3) Conditions contraindicated with Aripiprazole or Olanzapine.
Intervention groups
Psychotic patients referred to Farabi Hospital, Kermanshah
Main outcome variables
Body mass index, Efficacy of Olanzapine and Aripiprazole
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200430047250N1
Registration date:2020-09-11, 1399/06/21
Registration timing:registered_while_recruiting
Last update:2020-09-11, 1399/06/21
Update count:0
Registration date
2020-09-11, 1399/06/21
Registrant information
Name
Nima Gheitouly
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 3987
Email address
nimagheitouly@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-18, 1399/04/28
Expected recruitment end date
2021-07-08, 1400/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness and safety of Aripiprazole and Olanzapine in patients with psychotic disorders; A clinical trial
Public title
Evaluation of the efficacy of Olanzapine and Aripiprazole in patients with psychotic disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosing psychotic disorders through clinical interview and DSM-5 & ICSD-III criteria
Prescribing Aripiprazole or Olanzapine as a treatment strategy for psychotic disorders
Patients aged 18-64 years
Exclusion criteria:
Patients simultaneously taking medications such as sleeping pills and Aripiprazole or Olanzapine (drugs that have high sedative effects)
Patients suffering dependence on or abuse of Aripiprazole or Olanzapine
Patients with multiple chronic physical illnesses such as Diabetes, High Blood Pressure, and Rheumatism
Patients with certain health conditions( preventing them form taking Aripiprazole or Olanzapine )
Age
From 18 years old to 64 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
94
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinded individuals include:
Participants
Trialist (project executive)
Patients
Health staff
outcome adjudicators
Data Analysts
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah university of medical sciences
Street address
No48 ,Boostan Ave ,Roodaki Blvd, Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6714847691
Approval date
2020-07-18, 1399/04/28
Ethics committee reference number
IR.KUMS.REC.1399.376
Health conditions studied
1
Description of health condition studied
Psychotic Disorders
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of body mass index in psychotic patients treated with olanzapine or aripiprazole
Timepoint
At the beginning of the study and one and two months after starting the drug
Method of measurement
Height and weight scales
2
Description
Efficacy of olanzapine and aripiprazole in psychotic patients
Timepoint
At the beginning of the study and one and two months after starting the drug
Method of measurement
PANSS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study is a double-blind clinical trial. The study population includes all patients with psychotic disorders who in 1398, referred to Farabi Hospital in Kermanshah for treatment and have the criteria for inclusion in the study Inclusion criteria in this study include (diagnosis of psychotic disorders based on clinical interview and DSMv criteria and ICSD-III by a psychiatrist 2) Prescribing aripiprazole or olanzapine as a treatment strategy for psychotic disorders by a psychiatrist 3) In the age range of 18-64 years and exclusion criteria are also 1) People who take drugs such as hypnotics Take concomitantly with aripiprazole or olanzapine (drugs that have high sedative effects) 2) Patients who are abused or dependent on aripiprazole or olanzapine, 3) Patients with concomitant chronic physical illnesses such as diabetes, hypertension, And rheumatism 4) patients who are medically prohibited from taking aripiprazole or olanzapine. After explaining the purpose of the study, and obtaining informed consent, patients are randomly divided into two groups based on a table of random numbers. First, tests related to the presence or absence of metabolic syndrome, including blood sugar, blood lipids, etc. are taken from these people. Also, in order to measure body mass (BMI), height and weight of people are measured. Then, one of the members of the research team, who randomizes two groups of blinds, poses a questionnaire of positive and negative symptoms (PANSS) of these people. Becomes. In the next step, the psychiatrist prescribes one of the two drugs olanzapine and eripiprazole for the patient and provides the patient with the amount of the drug for one month. Also, the contact number is provided to the patient so that in case of any problem, he can discuss it with the psychiatrist. During the first month, patients are contacted once a week and asked about side effects. After one month, the contact number that was initially taken from the patient will be called and he will be asked to visit again. During this visit, the psychiatrist re-examines the patient and returns the medication. During this visit, the patient is sent back to the laboratory and the first stage tests are repeated for him. Also, his height and weight are re-evaluated by the first stage assessor to control body mass and PANSS questionnaire and side effects checklist based on DSMv Prepared is completed. Since the time required for the effect of these drugs is eight weeks or two months (14) after another month, ie after the end of two months, the patient is contacted again and the patient evaluation cycle, which was performed at the end of the first month, is repeated. Is repeated. It should be noted that if at the end of a month or the second month the patient has side effects or metabolic syndrome, the psychiatrist can change the patient based on the clinical condition. It is also used to control confounding variables such as the patient's arbitrary use of other drugs or to reduce the amount of drugs arbitrarily by calling the patient and reminding them. After two months, the information is entered in SPSS20 software and analyzed using statistical tests.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Adeleh Elahi
Street address
Ashayer Ave, Dolatabad Blvd, Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
67198851451
Phone
+98 83 3826 4802
Email
nimagheitouly@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid beheshti Blvd, Kermanshah university of Medical Science
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
daftarriasat@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
90
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
Kermanshah University of Medical Sciences
Full name of responsible person
Nima Gheitouly
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No48, bostan Ave, Roodaki Blvd, Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6714847691
Phone
+98 83 3428 3987
Email
nimagheitouly@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nima Gheitouly
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No48, bostan Ave, Roodaki Blvd, Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6714847691
Phone
+98 83 3428 3987
Email
nimagheitouly@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nima Gheitouly
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No48, bostan Ave, Roodaki Blvd, Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6714847691
Phone
+98 83 3428 3987
Email
nimagheitouly@yahoo.com
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