This study is a double blind placebo-controlled randomized clinical trial.according to inclusion criteria (having Obsessive Compulsive Disorder with Yale Brown Scale score more than 16 despite using of Selective Serotonin Reuptake Inhibitor or Clomipramine for at least 8 to 12 weeks with maximum tolerated dose) and exclusion criteria (past history of renal stone or having psychotic or mood disorder) 32 patient with refractory Obsessive Compulsive Disorder who referred to Isfahan Obsessive Compulsive Disorder clinics of Nour hospital randomly divided to two groups,cases and controls.
case group would be prescribed Topiramate and control group would be prescribed placebo and also two groups would continue their previous drugs(Selective Serotonin Reuptake Inhibitor and/or Clomipramine). paitients would be followed for 12 weeks.before intervention and after 1,2 and 3 month they would be evaluated using Yale Brown Scale and Clinical Global Impressions.
General information
Acronym
OCD
IRCT registration information
IRCT registration number:IRCT2013012312252N1
Registration date:2013-02-18, 1391/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-18, 1391/11/30
Registrant information
Name
Elham Zarean
Name of organization / entity
Isfahan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 0048
Email address
e_zarean@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2013-02-03, 1391/11/15
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of Topiramate augmentation in refractory Obsessive- Compulsive Disorder
Public title
Therapeutic effect of Topiramate in refractory Obsessive Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Obsessive Compulsive criteria according to DSM-IV-TR;
Be used maximum tolerated dose of SSRI or Clomipramine for at least 12 weeks;
moderate to severe symptoms according to Yale Brown Scale score more than 16;
informed consent
Exclusion criteria:primary diagnosis of psychotic or mood disorder(bipolar or MDD); subtance abuse or dependence; uncontrolled medical illness(e.g. DM,HTN,...); previous use of Topiramate; pregnancy or breastfeeding or who wants to be pregnant; convulsive disorder; suicidal thought; past history of renal stone
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Isfahan University Of Medical Science
Street address
Isfahan University Of Medical Sciencel, Daneshgah Bol
City
Isfahan
Postal code
8174673441
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
391144
Health conditions studied
1
Description of health condition studied
Obcessive Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive Compulsive Disorder
Primary outcomes
1
Description
Obsessive Compulsive Disorder severity
Timepoint
before intervention and after first,second and third month
Method of measurement
Yale Brown Scale and CGI scale
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Topiramate 25 mg would be prescribed daily and increased 25mg weekly with respect to patient tolerance.Treatment would be continued for 3 months
Category
Treatment - Drugs
2
Description
Tablet Placebo 25 mg would be prescribed daily and increased 25mg weekly with respect to patient tolerance.Treatment would be continued for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shariati Clinic of Psychiatry
Full name of responsible person
Dr SHahla Akuchekian
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Mr Toghyani
Street address
Isfahan University Of Medical Sciences, Daneshgah Bol
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Dr Elham Zarean
Position
residant
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences, Daneshgah Bol
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
Email
e_zarean@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical sciences
Full name of responsible person
Dr Shahla Akuchekian
Position
psychiatry specialization
Other areas of specialty/work
Street address
Isfahan University Of Medical sciences, Daneshgah Bol
City
Isfahan
Postal code
Phone
+98 66 80048
Fax
Email
akuchekian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr Elham Zarean
Position
resident
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences, Daneshgah Bol
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)