The sample of this interventional study includes 40 subjects with refractory OCD. In the parallel assignment, they will be randomly allocated into two groups. One group is a placebo control. The second group takes augmentation of N-Acetyl cystein. It is a double blind study that the subject, investigators, outcomes assessor are blind to the groups. The primary purpose of this study is treatment. The Experimental group will receive N-Acetylcysteine augmentation, at a standard dose titrated up to 1200 mg within three weeks, in addition to the medication regimen they are on at enrollment. Placebo group will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment. The ages eligible for Study is 10 to 20 years and it includes both genders
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103243930N4
Registration date:2011-04-11, 1390/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-11, 1390/01/22
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
N-Acetylcysteine Augmentation in Treatment of Refractory Obsessive-Compulsive Disorder, a double blind randomized placebo controlled clinical trial
Public title
N-Acetylcysteine Augmentation in Treatment of Refractory Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria are: DSM-IV diagnosis of OCD; symptoms of at least 1 year duration, moderate to severe OCD symptoms (Y-BOCS > 16), and failure of an adequate trial of an SSRI.
Exclusion Criteria are: primary diagnosis of a psychotic disorder, active substance abuse or dependence, unstable medical condition, prior exposure to N-Acetylcysteine, pregnancy, breastfeeding, or intent to become pregnant during study, evidence of active liver disease, seizure disorder, and active suicidal ideation.
Age
From 10 years old to 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Shiraz University of Medical Sciences
Street address
Zand Street, Shiraz University of Medical sciences- Vice-chancellery of Research Affairs
City
Shiraz
Postal code
Approval date
2010-12-30, 1389/10/09
Ethics committee reference number
Ct-89-2147
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
Yale-Brown Obsessive-Compulsive Scale
Timepoint
every 2 weeks for 10 weeks
Method of measurement
Interview
Secondary outcomes
1
Description
Clinical Global Impression
Timepoint
every 2 weeks for 10 weeks
Method of measurement
Self-report
Intervention groups
1
Description
N-Acetylcysteine (at a standard dose titrated up to 1200 mg within the first week) + SSRI
Category
Treatment - Drugs
2
Description
Placebo + SSRI
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Street address
Chamran Street, Hafez hospital
City
ُShiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Zand Street, Shiraz University of Medical sciences- Vice-chancellery of Research Affairs
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
M.D.
Other areas of specialty/work
Street address
Chamran street, Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)