This RCT aimed to compare augmentation effects of Aripiprazole versus Risperidone in treatment of refractory obsessive-compulsive disorder (OCD). In this double-blinded RCT, 100 patients which according on DSV-IV-TR has been recognized as the refractory OCD selected with non-random method. They were captured from psychiatry clinics of Kashan University of Medical Sciences. After acquiring consent from patients they were randomized into two identical groups. In addition to taking SSRI drugs for every group, we added daily dose of 5 mg Aripiperazole to one group and 1.5 mg to another group for 12 weeks.
The most important inclusion criteria were; Age between 18-60 years; the Yale-Brown obsessive-compulsive scale (Y-BOCS) ≥16 and suffering from OCD whilst were taken a therapeutic dose of SSRI drugs at least for 12 weeks. The most important exclusion criteria were; breast feeding and pregnancy, any acute or severe physical diseases occurring during the study, more than four weeks loss to follow-up. The efficacy of treatment as the primary outcome was measured by Yale-Brown Obsessive Compulsive Scale score and was compared before trial and in 4th, 8th and 12th weeks and any severe side effects of traetment were measured as the secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110424882N1
Registration date:2016-08-04, 1395/05/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Mahboobeh Borna
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5547 1370
Email address
mahboobehborna@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey about comparison of augmentation therapy in refractory obsessive-compulsive disorder patients; Aripiprazole vs. Risperidone
Public title
Augmentation therapy comparison in refractory obsessive-compulsive disorder with Aripiprazole vs. Risperidone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-60 years;the Yale-Brown obsessive-compulsive scale (Y-BOCS) ≥16 and suffering from OCD whilst were taken a therapeutic dose of SSRI drugs at least for 12 weeks;negative history of: pregnant or breastfeeding in women; psychotic, bipolar mood, and severe depressive disorders in DSM-IV-TR axis I; any known disorder in DSM-IV-TR axis II like personality disorders or mental retardation; drug and alcohol abuse in the last six months before study; any physical disease impeding the use of Risperidone or Aripiprazole; not psychotherapy during the study.
Exclusion criteria: Any acute or severe physical diseases occurring during the study; more than four weeks loss to follow-up; severe side effects during the study; not using contraceptive methods in females.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ثبت نشده
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences ethic commetee in health sciences
Street address
Ghotbe ravandi, Blv, Vice Chancellor of Research & Technology
City
Kashan
Postal code
8715988141
Approval date
2013-08-22, 1392/05/31
Ethics committee reference number
9270
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Severity of symptoms of OCD
Timepoint
Basline and every 4 weeks
Method of measurement
Y_BOCS
Secondary outcomes
1
Description
Unwanted side effects of drugs
Timepoint
Every 4 weeks
Method of measurement
Interview
Intervention groups
1
Description
In a group of patients in addition to SSRI drugs, Aripiprazole, production of sobhan corporation, begun with 2.5 mg and increased gradually to 10 mg, at the end of second week. All of patients were visited 8 times by psychiatrist. In cases of side effects incidence it was treated by lowering doses of drug and beginning more gradually, again or was taken necessary drugs (Propranolol, Lorazepam and Piperidine) to control side effects
Category
Treatment - Drugs
2
Description
In other group also, in addition to SSRI drugs, Risperidone, production of sobhan corporation, begun with 1 mg and increased gradually to 2 mg, at the end of the first week. All of patients were visited 8 times by psychiatrist. In cases of side effects incidence it was treated by lowering doses of drug and beginning more gradually, again or was taken necessary drugs (Propranolol, Lorazepam and Piperidine) to control side effects
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinical psychiatrist of Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Assarian
Street address
Ghotbe ravanvi Blv. Kargarnegad hospital
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences, Dr Gholamali Hamidi
Full name of responsible person
Dr Fatemeh Assarian
Street address
Ghotbe ravandi Blv. Kargarnejad hospital
City
Kashan
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, Dr Gholamali Hamidi
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Fatemeh Assarian
Position
َAssistant professor
Other areas of specialty/work
Street address
Ghotbe ravandi Blv. Kargarnejad hospital
City
Kashan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
fa_assar@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
Dr Fatemeh Assarian
Position
Assistan professor
Other areas of specialty/work
Street address
Ghotbe ravandi Blv. Kargarnead hospital
City
Kashan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
fa_assar@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
Dr Mahboobeh Borna
Position
resident
Other areas of specialty/work
Street address
Ghotbe ravandi Blv. Kargarnejad hospital
City
Kashan
Postal code
8715973446
Phone
+98 31 5547 1370
Fax
Email
mahboobehborna@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)