Obsessive-Compulsive Disorder (OCD) is known by recurrent and intrusive dystressfull thoughts, images and impulses(obsessions) and recurrent and goal-directed behaviors that patient has to do those(Compulsive). Pharmacological treatment by Selective-Serotonin Re-uptake Inhibitors(SSRIs) and a Tricyclic Anti-Depressant (Clomipramine) is effective for this condition, but 20% of patients are known as treatment-resistant and 20-30% of them show relative response. It seems that addition of a 5HT3 antagonist such as Ondansetrone and Granisetrone to a SSRI has potential efficacy. Therefore with have decided to evaluate efficacy and safety of another member of this drug group, Tropisetrone, for treatment of OCD. This study will perform as a randomized double-blind clinical trial in 10 weeks. 50 outpatient who meet DSM-IV-TR criterion of OCD by structured clinical interview will be divided randomly into 2 arms (one will be treated by Tropisetrone 5mg daily and Fluvoxamine 100mg for 4 first weeks and 200 upcoming weeks, another will be treated by similar pattern and dosage of Fluvoxamine and Placebo). Participants will be evaluated by YBOCS and drug side effects checklist in 0,4,8,10 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012332145N1
Registration date:2017-02-13, 1395/11/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Mohammadreza Shalbafan
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1665
Email address
shalbafan.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tropisetron as an Adjuvant Therapy for Obsessive-compulsive Disorder: A Double-blind, Placebo-controlled, Randomized Trial
Public title
Tropisetron for treatment of Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Patients who meet DSM-IV-TR criterion for OCD and they achieve more than 21 for Yale-Brown Obsessive Compulsive Scale are suitable for study. They should be 18-60 years old and sign consent form. they should not be treated by any psychiatric interventions for 6 weeks ago. If they show any other mental important conditions or suicidal thoughts, neurological deficits, exclude from study. They will evaluate for cardiac, liver, kidney, pregnancy, lactation and mental retardation before entrance and any mentioned conditions will cause exclusion from study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2016-12-28, 1395/10/08
Ethics committee reference number
IR.IUMS.REC.1395.95-03-121-29352
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 obsessive-compulsive disorder
Timepoint
Weeks: 0, 4, 8 and 10
Method of measurement
Yale-Brown Obsessive Compulsive Scale(YBOCS)
Secondary outcomes
1
Description
Side effects
Timepoint
Weeks: 0, 4, 8 and 10
Method of measurement
Checklist
Intervention groups
1
Description
Tropisetrone capsul 5mg daily and Fluvoxamine tablet 100mg daily for 4 first weeks and 2 per day for upcoming weeks. Oral ingestion is route of prescription.
Category
Treatment - Drugs
2
Description
Placebo capsul daily and Fluvoxamine tablet 100mg daily for 4 first weeks and 2 per day for upcoming weeks. Oral ingestion is route of prescription.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatry Hospital
Full name of responsible person
Dr Mohammadreza Shalbafan
Street address
Tehran-Karaj 7 km, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Tehran Psychiatry Institute
Full name of responsible person
Dr Mohammadreza Shalbafan
Street address
Mansoori St., Niayesh St.,Sattarkhan St., Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, Baharloo Hospital
Full name of responsible person
Dr Shahin Akhondzadeh
Street address
Keshavarz Blvd., Tehran
City
Tehran
4
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Dr Seyed Ali Dastgheyb
Street address
City
Shiraz
5
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Dr Zahra Ghiasi
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Shalbafan
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Shalbafan
Position
Psychiatrist/ Assistant Prof.
Other areas of specialty/work
Street address
Iran Psychiatry Hospital, Tehran-Karaj Exp. way 7th Km, Tehran
City
Tehran
Postal code
Phone
+98 21 4452 5615
Fax
+98 21 6655 1665
Email
shalbafan.mr@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Shalbafan
Position
Psychiatrist/ Assistant Prof.
Other areas of specialty/work
Street address
Iran Psychiatry Hospital, Tehran-Karaj Exp. way 7th Km, Tehran
City
Tehran
Postal code
Phone
+98 21 4452 5615
Fax
+98 21 6655 1665
Email
shalbafan.mr@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Shalbafan
Position
Psychiatrist/ Assistant Prof.
Other areas of specialty/work
Street address
Iran Psychiatry Hospital, Tehran-Karaj Exp.way 7th Km, Tehran
City
Tehran
Postal code
Phone
+98 21 4452 5615
Fax
+98 21 6655 1665
Email
shalbafan.mr@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)