Comparing the change of biochemical factors in serum of patients with bipolar disorder who receive Aripiprazol and Perfenazin
Design
A randomized clinical trial without control group, with parallel groups, phase 3، without blindness in which 60 patients randomly divided into two groups of 30 subjects using block randomization method and blocks of size 4 and 6.
Settings and conduct
In this study, patients with bipolar disorder who are candidate for antipsychotic drug therapy at Shahid Yahya Nejad Hospital in Babol were randomly divided into two Intervention groups. After 3 month, biochemical factors were checked and compared for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No Psychotic symptom; Bipolar disorder diagnosis based on DSM-4-TR; Filling in the personal satisfaction form; Age between 18-50 years.
Exclusion Criteria: Hypertension; High blood lipids; Antihypertensive and antilipid drugs؛ Diabetes mellitus type-II; Physical disorders; Pregnancy
Intervention groups
Intervention group 1:Tablet Aripiprazole 10 mg (Jalinous Company) with dose range (10-30) and Tablet Sodium Valproate 200 mg (Hakim Company).
Intervention group 2: Tablet Perphenazine 8 mg ( Darupakhsh Company) with dose range (32-24) And Tablet Sodium Valproate 200 mg (Hakim Company)
Main outcome variables
Biochemical Factors including Fasting Blood Suger; Triglyceride; Cholesterol; HDL; LDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170606034348N6
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 121 3171
Email address
a.hamidia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing changes of biochemical factors in serum of patients with bipolar disorder who received Aripiprazol versus Perfenazin
Public title
The effect of Aripiprazol and Perfenazinpatients on biochemical factors among patients with bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No Psychotic symptom
Bipolar disorder diagnosis based on DSM-4-TR
Filling in the personal satisfaction form
Ages between 18-50 years
Exclusion criteria:
Hypertension
High blood lipids
Antihypertensive and antihypertensive drugs
Diabetes mellitus type-II
Physical disorders
Pregnancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly divided into two groups of 30 subjects with blocks of size 4 and 6 and an allocation ratio of 1: 1. The participants allocation sequence in two groups was performed with Randomizer software. Opaque sealed sequentially numbered envelops used for allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
babol
Province
Mazandaran
Postal code
4713566547
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.278
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Fasting Blood Suger
Timepoint
Before treatment and three months after treatment
Method of measurement
Laboratory test
2
Description
Triglyceride
Timepoint
Before treatment and three months after treatment
Method of measurement
Laboratory test
3
Description
Cholesterol
Timepoint
Before treatment and three months after treatment
Method of measurement
Laboratory test
4
Description
HDL
Timepoint
Before treatment and three months after treatment
Method of measurement
Laboratory test
5
Description
LDL
Timepoint
Before treatment and three months after treatment
Method of measurement
Laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:Aripiprazole, 10 mg tablet (produced by Jalinous Company) with dose range of 10-30 and Sodium Valproate 200 mg tablet (produced by Hakim Company) for 3 months.
Category
Treatment - Drugs
2
Description
Intervention group: Perphenazine, 8 mg tablet (produced by Darupakhsh company) and Sodium Valproate, 200 mg tablet (produced by Hakim company) for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Yahya Nejad Hospital
Full name of responsible person
Dr.Azam Ali Akbarian
Street address
Mustafa Khomeini street
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3239 1951
Fax
+98 11 3239 1951
Email
a.aliakbarian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Vice-chancellor for Research, Daneshgah square, Ganjafrooz avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Jomhoory Eslami street
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
angela_7633@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Jomhoory Eslami street
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
angela_7633@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Jomhoory Eslami street
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
angela_7633@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available