Several case reports have reported efficacy of anti-glutamatergic medications for the treatment of OCD. The objective of this study was to investigate the efficacy of NAC, an anti-glutamatergic medication with a unique pharmacodynamic profile, in individuals with resistant OCD. Participants in this study will be 72 Patients referred to the Anxiety Disorders Clinic of Farshchian Hospital of Hamadan and Noor Hospital of Isfahan who have resistant Obsessive Compulsive Disorder, and are accepted for treatment at the clinics. The patients will be divided randomly in two groups to receive either 2400 mg NAC (4 tablets) or placebo for 12 weeks. Severity of OCD will be measured with YBOCS and CGI Scale at the baseline and every 4 weeks during intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806101743N2
Registration date:2009-10-12, 1388/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-10-12, 1388/07/20
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
NAC add on to the treatment of refractory obssessive compulsive disorder
Public title
NAC add on to the treatment of refractory obssessive compulsive disorder: A double-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Suffering from OCD, taking a therapeutic dose of a SSRI or Clomipramine, at least for 12 weeks, Y_BOSC score of 16 or greater Exclusion criteria: primary diagnosis of psychosis or bipolar mood disorder, substance abuse or dependency, uncontrolled medical condition, having had a pervious trial of Memantine, pregnancy or breast feeding, rising liver enzymes to more than twice of normal range during intervention, presence of epilepsy, presence of suicidal thinking, presence of MDD
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2009-05-10, 1388/02/20
Ethics committee reference number
38378/9/35/16/پ
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 and CGI Scale
Secondary outcomes
empty
Intervention groups
1
Description
NAC, 2400 mg, daily, for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo, 2400 mg, daily, for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Anxiety Clinic of Farshchian Hospital
Full name of responsible person
Dr.Hafezian
Street address
Farshchian Hospital
City
Hamadan
2
Recruitment center
Name of recruitment center
Noor Hospital of Isfahan
Full name of responsible person
Dr. Hamid Mohammadbeigi
Street address
Ostandary street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center for Behavioral Disorder and Substance Abuse, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ali Ghaleiha
Street address
Honarestan street.Farshchian Hospital
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center for Behavioral Disorder and Substance Abuse, Hamadan 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
Name of organization / entity
Full name of responsible person
Hamid Mohammadbigi
Position
Psychiatrist, Assdistant Professor
Other areas of specialty/work
Street address
Nor Hospital of Esfahan
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Full name of responsible person
Dr.Mohammad Haghighi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
Phone
Fax
Email
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)