Comparison Aripiprazole & Risperidone effectiveness in treating obsessive-compulsive in patients with bipolar disorder
Design
A randomized clinical trial without control group, with parallel groups, phase 3، without blindness that, 60 patients randomly divided into two groups of 30 subjects with block sizes of 4 and 6.
Settings and conduct
The population of this study was aged 18-55 years old who referred to Yahya Nezhad Hospital in Babol. Patients are randomly divided into two Intervention groups with a table of random numbers by computer.Intervention group 1: Aripiprazole (Sobhan Company) Begins with an initial dose of 2.5 mg per day and gradually increased to a dose of 5 to 20 mg per day.
Intervention group 2: Raspidron (Porsina)Begins with an initial dose of 0.5 mg per day and gradually increased to a dose of 1 to 4 mg per day.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with bipolar mood disorder, Have not Major medical problem (cardiovascular, respiratory, renal and gastrointestinal disease)
Exclusion Criteria: Pregnancy, alcohol or other substances abuser
Intervention groups
Intervention group 1: Aripiprazole (Sobhan Company) Begins with an initial dose of 2.5 mg per day and gradually increased to a dose of 5 to 20 mg per day.
Intervention group 2: Raspidron (Porsina)Begins with an initial dose of 0.5 mg per day and gradually increased to a dose of 1 to 4 mg per day.
Main outcome variables
Efficacy of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200614047761N1
Registration date:2020-06-18, 1399/03/29
Registration timing:registered_while_recruiting
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
sekineh javadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
s.javadian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-09, 1399/01/21
Expected recruitment end date
2021-04-10, 1400/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Aripiprazole & Risperidone effectiveness in treating obsessive-compulsive disorder in patients with Bipolar disorder
Public title
Treating obsessive-compulsive disorder in patients with Bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bipolar mood disorder
Have not Major medical problem (cardiovascular, respiratory, renal and gastrointestinal disease)
Exclusion criteria:
Pregnancy
alcohol or other substances abuser
Age
From 18 years old to 60 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 four and six blocks and an allocation ratio of 1: 1.The participants allocation sequence in two groups performed with a Randomizer software. Opaque sealed sequentially numbered envelops used for allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.MUBABOL.REC.1399.072
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
2
Description of health condition studied
Obsessive-Compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
obsessive-compulsive signs&symptoms in bipolar disorder patients
Timepoint
before intervention and then monthly for 4 months
Method of measurement
Yale- Brown Obsessive Compulsive Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aripiprazole (Sobhan Company) Begins with an initial dose of 2.5 mg per day and gradually increased to a dose of 5 to 20 mg per day
Category
Treatment - Drugs
2
Description
Intervention group: Raspidron (Porsina)Begins with an initial dose of 0.5 mg per day and gradually increased to a dose of 1 to 4 mg per day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahya Nezhad Hospital
Full name of responsible person
Sekineh Javadian
Street address
Shahid Mostafa Khomeini St., Modarres St
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 5035
Email
s.javadian@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 7669
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
Sekineh Javadian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 2033
Email
s.javadian@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sekineh Javadian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 2033
Email
s.javadian@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sekineh Javadian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol university of medical sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 2033
Email
s.javadian@mubabol.ac.ir
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
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