The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of granisetron would improve psychopathology in subjects with OCD treated with fluvoxamine. 40 patients with chronic DSM-IV-diagnosed OCD will receive fluvoxamine(200 mg/day) combined with either placebo (N=20) or 2 mg/day granisetron(N=20) for 8 weeks. Efficacy will be defined as the change from baseline to endpoint in score on the Yale-Brown obsessive compulsive scale(Y-B ocs).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202041556N32
Registration date:2012-02-06, 1390/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-06, 1390/11/17
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-11-01, 1390/08/10
Expected recruitment end date
2012-05-01, 1391/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Granisetron in the treatment of obsessive-compulsive disorder: a double-blind, placebo controlled trial
Public title
Granisetron in the treatment of obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:Age between 18-60; Diagnosis of OCD based on DSM IV; Minimum Score of 21 on YALE-BROWN Obsessive-Compulsive Scale- Exclusion Criteria: Substance dependence; IQ <70; any other mental disorder on axis I; Any serious cardiac, renal or hepatic disease ; receiving psychotropic medications during the last 6 weeks ; pregnancy orbreast feeding; rising liver transaminases to three times the upper limit of normal or higher
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2011-04-04, 1390/01/15
Ethics committee reference number
10387
Health conditions studied
1
Description of health condition studied
Obsessive- Cumpulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive- Cumpulsive Disorder
Primary outcomes
1
Description
Severity of symptoms of OCD
Timepoint
Baseline and weeks 2-4-6-8 after beginig of treatment
Method of measurement
by Y-BOCS Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Tablet fluvoxamine (200 mg/day) combined with 2 mg/day of Tablets granisetron as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Tablet fluvoxamine (200 mg/day) combined with placebo as control group for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
South kargar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Akbar Fotouhi
Street address
Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Ph.D. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Ph.D. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)