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 Memantine, an anti-glutamatergic medication with a unique pharmacodynamic profile, in individuals with resistant OCD. Participants in the study will be 72 Patients referred to the Anxiety Disorders Clinic of Farshchian Hospital who have primary diagnosis of resistant Obsessive Compulsive Disorder, and are accepted for treatment at the clinic. The patients will be divided randomly in two groups to receive 10 mg per day Memantine or placebo for 12 weeks. Severity of disorder will be measured with YBOCS and CGI Scale at the beginning of the intervention and every 4 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712141743N1
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
Research Center for Behavioral Disorder and Substance Abuse, Hamadan University of Medical Sciences
Expected recruitment start date
2009-09-01, 1388/06/10
Expected recruitment end date
2010-03-01, 1388/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Memantine add on to treatment of refractory obssessive compulsive disorder
Public title
Memantine add on to 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 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,Hamadan university of Medical science
City
Hamadan
Postal code
Approval date
2009-05-10, 1388/02/20
Ethics committee reference number
38374/9/35/16
Health conditions studied
1
Description of health condition studied
Obsessive- Cumpulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Severity of symptoms of OCD
Timepoint
4 weeks
Method of measurement
Y_BOCS and CGI Scale
Secondary outcomes
empty
Intervention groups
1
Description
Memantine, 10 mg, BD, for 12 weeks
Category
Treatment - Drugs
2
Description
placebo, 10 mg, BD,for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital of Hamadan.
Full name of responsible person
Dr. Mohammad Haghighi
Street address
Honaresatan street
City
Hamadan
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
Hamadan University of medical Sciences
Full name of responsible person
Dr. Hassan Hafezian
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
Phone
+98 81 1827 4184
Fax
Email
hhafezian@yhoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan university of Medical sciences
Full name of responsible person
Mohammad Haghighi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
Phone
Fax
Email
dr_haghighi_ps@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)