Patients with resistance OCD receive placebo or Atorvastatine in this clinical trial and after 12 weeks, Y-BOCS will be completed. Comparison between study groups at baseline and at the end of week 12 was performed using the Mann-Whitney U test for two independent samples. In addition, an intention-to-treat analysis with last observation carried forward (LOCF) was performed to ensure that dropouts had not produced result bias.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511217290N2
Registration date:2015-12-14, 1394/09/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-14, 1394/09/23
Registrant information
Name
Mehdi Sayyah Bargard
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7571
Email address
sayah_bargard@hotmail.com
Recruitment status
Recruitment complete
Funding source
Jundishapur University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A primary evaluation of the effects of Atorvastatin on treatment-resistant obsessive compulsive disorder
Public title
Atorvastatin in OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: resistant OCD (a patient should undergo continuous monotherapy treatment with SSRIs for three months in order to be defined as resistant); Signing inform consent.
Exclusion criteria: the patients did not have any innate neurological disorders, and laboratory test results for blood count; liver and renal functions were abnormal; a A minimum score of 21 in the Yale–Brown Scale (Y-BOCS) for OCD; breast feeding; pregnant women.
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapur University of Medical Sciences
Street address
Deputy of reaserch and technology, Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
IR.AJUMS.REC.1394.108
Health conditions studied
1
Description of health condition studied
OCD
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Yale brown Scale
Timepoint
0 and 12th week after intervention
Method of measurement
Questionnaire completed by psychiatrist
Secondary outcomes
1
Description
Side effect
Timepoint
0 and 12th week after intervention
Method of measurement
Patients' medical report
Intervention groups
1
Description
Drug Group , atorvastatin
Category
Treatment - Drugs
2
Description
Placebo group , similar to Atorvastatin (Starch)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
number 42,Azdegan AVE
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Reaserch and Techonology
Full name of responsible person
Dr. Saki
Street address
Deputy of reaserch and technology, Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Reaserch and Techonology
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
Jundishapur University of Medical Sciences
Full name of responsible person
Mehdi Sayyah Bargard
Position
Faculty member
Other areas of specialty/work
Street address
EDC,Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3336 7671
Fax
Email
sayah_bargar@Aol.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Mehdi Sayyah Bargard
Position
Assisstant profossor
Other areas of specialty/work
Street address
EDC,Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3336 7571
Fax
Email
sayah_bargard@Aol.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Mehdi Sayyah Bargard
Position
Psychiatrist
Other areas of specialty/work
Street address
EDC, Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3336 7571
Fax
Email
sayah_bargard@aol.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)