Comparison of the Effectiveness of Aripiprazole and Risperidone in Improving Obsessive-compulsive symptoms in Bipolar patients Comorbid Obsessive-compulsive disorder
Comparison of the efficacy of Aripiprazole and Risperidone in the treatment of Obsessive-Compulsive Symptoms in Bipolar patients with Obsessive-Compulsive Disorder
Design
In this study, 60 patients with Bipolar Disorder with Obsessive-Compulsive Disorder are enrolled on the basis of DSM-5 criteria. The companies are randomly divided into two groups and each participant is assigned a code.
Settings and conduct
60 eligible patients with Bipolar Disorder with comorbid Obsessive-Compulsive Disorder and referred to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study.Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion Criteria are definitive diagnosis of Bipolar Disorder with Obsessive-Compulsive Disorder based on DSM-5 criteria, Age 18 to 65 years and Exclusion Criteria are acute and severe physical illness during study,Substance abuse and alcohol abuse in the six months before study,Accompanied with other psychiatric disorders.
Intervention groups
The first group is given a dose of 2.5 mg of Aripiprazole and is gradually increased every 5 days 2.5 mg daily for up to 10 mg per day for 15 days and continues for up to 12 weeks.The second group starts the 1-mg dose of Risperidone and gradually releases to the end of the second week at a dose of 4 mg per day and lasts for up to 12 weeks.
Main outcome variables
Comparison of the mean score of Y-BOCS in the group receiving Aripiprazole at the beginning and end of study.Comparison of the mean score of Y-BOCS in the group receiving Risperidone at the beginning and end of study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170716035117N1
Registration date:2018-01-01, 1396/10/11
Registration timing:retrospective
Last update:2018-01-01, 1396/10/11
Update count:0
Registration date
2018-01-01, 1396/10/11
Registrant information
Name
Reza Kookalani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5541 0126
Email address
kookalani-r@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Aripiprazole and Risperidone in Improving Obsessive-compulsive symptoms in Bipolar patients Comorbid Obsessive-compulsive disorder
Public title
Effect of Aripiprazole and Risperidone in Improving Obsessive-compulsive symptoms in Bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 and 65 years
A definitive diagnosis of Bipolar disorder with Obsessive-compulsive disorder based on DSM-5 criteria
Bipolar patients in Maintenance phase
Patients with ability to answer and evaluate with Yale Brown scale (Higher education level)
Patients with Yale-Brown Obsessive-Compulsive Scale 16 or higher
Exclusion criteria:
Acute and severe physical illness during study
Presence of unsafe pregnancy prevention method in women of reproductive age
Pregnancy
Bearst feeding
Substance abuse and alcohol abuse in the six months before study
Accompanied with other psychiatric disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind (both patients and researchers) in your study are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kshan University of Medical Sciencesa
Street address
Ghotbe Ravand Boulevard, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.KAUMS.REC.1396.23
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
2
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Severity obsessive compulsion
Timepoint
The beginning of the study and every four weeks until the twelfth week
Method of measurement
Yale Brown Obsessive-Compulsion Scale
Secondary outcomes
1
Description
The onset of side effects of drugs
Timepoint
Weeks four, eighth, twelfth
Method of measurement
Clinical examination
Intervention groups
1
Description
First intervention group: In addition to peptic stabilizers, aripiprazole is started at a dose of 2.5 mg and gradually administered to the end of the second week to 10 mg per day. The duration of use is 12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group2:In addition to mood stabilizers, Risperidone was started by 1 mg and gradually received 2 mg / day until the end of the first week.Duration of use is 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Qorishi
Street address
Kargar Nejad Hospital, Qotb Ravandi Blvd
City
Esfahan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
kargarnejad@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Ghotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5557 5057
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fatemesadat Qoreishi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kargar Nejad Hospital, Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
dr.zoghoreishi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fateme Sadat Qoreishi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kargar nejad Hospital, Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
dr.zoghoreishi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Reza Kookalani
Position
Assistant Of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kargar nejad Hospital, Qotb Ravandi blvd
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
rezakookalani@gmail.com
Web page address
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