Comparison of Ondansetron and Granisetron Effectiveness in the Treatment of Obsessive-Compulsive Disorder with Inadequate Response to Selective Serotonin Reuptake Inhibitors
Comparison of Ondansetron and Granisetron Effectiveness in the Treatment of Obsessive-Compulsive Disorder
Design
A randomized, double-blind, placebo-controlled, phase III clinical trial was conducted on 104 patients with obsessive-compulsive disorder. Patients were divided into three groups that either received 18 weeks of ondansetron (intervention group 1), granisetron (intervention group 1) or placebo (control group) in addition to baseline treatment with selective serotonin reuptake inhibitors. Randomization of patients was done using the random permuted block method (allocation ratio 1:1, blocks of four).
Settings and conduct
Ondonestrone and granisetron are inhibitors of serotonin receptors. This clinical trial is conducted among outpatients of the psychiatric department of Amir Kabir Hospital, Arak. Patients were enrolled in the intervention group 1 (Ondosanone), intervention group 2 (granisetron) and control (placebo).The patients, the psychiatrist who referred the patients, the general practitioner who evaluated the patients and prescribed the medication were all blind to allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Resistant or inadequacy of Serotonin reuptake inhibitor (SRIs) treatment response.
Exclusion criteria: other significant psychiatric disorders
Recent receiving antipsychotics in the treatment of obsessive-compulsive disorder, having significant cardiovascular, hepatic, renal or pulmonary diseases
Intervention groups
Intervention group 1: Oral ondansetron tablet 2 mg in twice daily (4 mg daily) for 18 weeks.
Intervention group 2: Oral granisetron tablet 1 mg in twice daily (2 mg daily) for 18 weeks.
Control group:Oral placebo tablets were administered daily for 18 weeks.
Main outcome variables
Changes from baseline Yale-Brown Obsessive Compulsive Scale (YBOCS) total, Obsession and Compulsion subscale score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130726014170N2
Registration date:2018-04-23, 1397/02/03
Registration timing:retrospective
Last update:2018-04-23, 1397/02/03
Update count:0
Registration date
2018-04-23, 1397/02/03
Registrant information
Name
Mojtaba Sharafkhah
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 918 0298
Email address
sharafkhah@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-08-20, 1393/05/29
Expected recruitment end date
2016-09-19, 1395/06/29
Actual recruitment start date
2014-12-21, 1393/09/30
Actual recruitment end date
2017-09-20, 1396/06/29
Trial completion date
empty
Scientific title
Comparison of Ondansetron and Granisetron Effectiveness in the Treatment of Obsessive-Compulsive Disorder with Inadequate Response to Selective Serotonin Reuptake Inhibitors
Public title
The Effectiveness of Ondonestrone and Granisetron in the Treatment of Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of OCD established by clinical interview (using The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Axis I Disorders)
Resistant or inadequacy of Serotonin reuptake inhibitor (SRIs) treatment response
Exclusion criteria:
Diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, substance dependence or abuse, and other comorbid DSM-IV Axis I disorders
History of seizure, suicidal ideationو and significant head trauma
Recent receiving antipsychotics in the treatment of obsessive-compulsive disorder
Intelligence quotient less than 70
history of treatment resistance
pregnancy and/or lactation
Having significant cardiovascular, hepatic, renal or pulmonary diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
104
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients is based on the use of the random permuted block method (allocation ratio 1:1, blocks of four). Treatment allocation is concealed from the participants and physicians rated the patients using sequentially numbered, opaque and sealed envelopes. Randomizations and ratings of the patients are performed by separate individuals.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, the psychologist who referred the patients, the general physician and psychologist who evaluated the patients and prescribed the medication and the statistician were all blind to allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Shahid Shiroodi St., Aalam Al-Hoda St., Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2014-08-05, 1393/05/14
Ethics committee reference number
93-166-5
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
changes from baseline Yale-Brown Obsessive Compulsive Scale (YBOCS) total, Obsession and Compulsion subscale score
Timepoint
Every two weeks for 18 weeks
Method of measurement
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Secondary outcomes
1
Description
Partial treatment response
Timepoint
Every two weeks for 18 weeks
Method of measurement
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Intervention groups
1
Description
Intervention group: Continued treatment with serotonin reuptake inhibitor along with oral ondansetron tablet 2 mg in twice daily (4 mg daily) for 18 weeks. Ondansetron was provided by Jaber Ibn Hayyan pharmaceutical company,Tehran, Iran.
Category
Treatment - Drugs
2
Description
Intervention group: Continued treatment with serotonin reuptake inhibitor along with oral granisetron tablet 1 mg in twice daily (2 mg daily) for 18 weeks. Granisetron was provided by Jaber Ibn Hayyan pharmaceutical company,Tehran, Iran.
Category
Treatment - Drugs
3
Description
Control group: Oral placebo tablets were administered daily for 18 weeks. The placebo were provided by Jaber Ibn Hayyan pharmaceutical company, Iran.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir hospital
Full name of responsible person
Mohsen Rahimi
Street address
Shahid Shiroodi Street, Amir Kabir Hospital
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Akram Moslemi
Street address
Basij Square, Sardasht, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3639
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Sharafkhah
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
No. 4, Shaghayegh 24 Ave, Kochaksara street
City
قائم شهر
Province
Mazandaran
Postal code
4763658894
Phone
+98 11 4224 8158
Email
dr.sharafkhah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Sharafkhah
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
No. 4, Shaghayegh 24 Ave, Kochaksara street
City
Ghaemshahr
Province
Mazandaran
Postal code
4763658894
Phone
+98 11 4224 8158
Email
dr.sharafkhah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Sharafkhah
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
No. 4, Shaghayegh 24 Ave, Kochaksara street
City
Ghaemshahr
Province
Mazandaran
Postal code
4763658894
Phone
+98 11 4224 8158
Email
dr.sharafkhah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD