The study of the effect of ondansetron on the treatment of resistant obsessive compulsive disorder
Design
This is a two-blind clinical trial that will be conducted in Kashan University of Medical Sciences for 12 weeks in 1396. Cases will select from patients diagnosed by psychiatrist who meet DSM-5 criteria referring to psychiatric clinics affiliated to Kashan university of medical scinces .These patient will divide to two groups of 20 people
Settings and conduct
This is a two-blind clinical trial that will be conducted in Kashan University of Medical Sciences for 12 weeks in 1396.Creation,on the one hand ,is the lack knowledge of the psychiatrist of the distrbution of drugs between the patients,and the blind side of patient who has no information about the type of drug used. Dispensing will done by a psychiatric nurse and the psychiatrist. The facilitator will only examine the patients on the Yale Brown Scale. This study will take long about 3 months.
Participants/Inclusion and exclusion criteria
1. Aged 18 years and over. 2. Despite received at least three months of adequate and tolerable SSRI drugs, the scores of obsessive-compulsive scores 16 and up. 3. No pregnancy or breastfeeding in women. 4. No psychiatric disorder such as Bipolar in the axis 1 of psychiatry. 5. Lack of mental retardation in the axis 2 of psychiatry. 6. Lack of alcohol intake 6 months before the study. 7. Lack of physical disease that prevents the ondansetron release. 8. Lack of psychotherapy during the study; Exit of study: 1. Acute and severe physical illness during the study. 2. Non-follow-up for 4 weeks. 3. Severe complications during treatment.4 not using contraceptive methods in females
Intervention groups
Patients will divided into two groups. The first group will receive SSRI and ondansetrone at a dose of 8 mg daily and the other will receive SSRI and placebo.T
Main outcome variables
1- Determination of demographic characteristics of patients participating in the study -
2- Determine the median of the score - Y-BOCS in the two groups in the week zero. Fourth. Eighth and twelfth
3- Comparison of the mean score of Y-BOCS in two groups at week zero. Fourth. Eighth and twelfth
4- Comparison of mean scores - Y = BOCS in the group receiving ondansetron and placebo in terms of confounding variables
By gender. The drug is consumed during the period of illness and the age of the onset of the disease
5- Determine the response rate to treatment in the two groups in the fourth week. Eighth and -Twelve
6- Comparison of the response rate to treatment in the two groups in the fourth week. Eighth and Twelve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170723035247N1
Registration date:2018-01-03, 1396/10/13
Registration timing:retrospective
Last update:2018-01-03, 1396/10/13
Update count:0
Registration date
2018-01-03, 1396/10/13
Registrant information
Name
Mehdi Adel
Name of organization / entity
Kashan University of Medical Scinence
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 9111
Email address
adel-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Science
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2017-06-21, 1396/03/31
Actual recruitment end date
2017-08-22, 1396/05/31
Trial completion date
empty
Scientific title
The effect of Ondansetron augmentation in tretment resistant obsessive-copulsive disorder
Public title
The effect of Ondansetron to tretment obsessive -copmpulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 years and over.
Despite received at least three months of adequate and tolerable SSRI drugs, the scores of obsessive-compulsive scores 16 and up.
No pregnancy or breastfeeding in women.
No psychiatric disorder such as Bipolar in the axis 1 of psychiatry.
Lack of mental retardation in the axis 2 of psychiatry.
Lack of alcohol intake 6 months before the study.
Lack of psychotherapy during the study.
Exclusion criteria:
Acute and severe physical illness during the study.
Non-follow-up for 4 weeks.
Severe complications during treatment.
Not using contraceptive methods in females
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 and Safety Monitoring Board
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness on the one hand is the lack of knowledge of the distributor's psychiatrist about the distribution of drugs among the patients, and the blind on the other side, which patients do not know the type of drug (ondansetron or placebo). The distribution of the medicine will be done by the nurse and the psychiatrist will examine the patients in terms of the scale of Yale-Brown
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences ethic commetee in health sciences
Street address
Medical college, Ghotb Ravandi boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
Approval date
2016-09-27, 1395/07/06
Ethics committee reference number
IR.KAUMS.REC.1395.66
Health conditions studied
1
Description of health condition studied
Obsessive -compulsive disorder
ICD-10 code
F42
ICD-10 code description
F42-The essential feature is recurrent obsessional thoughts or compulsive acts.obsessional thoughts are ideas,images,or impuses that enter the patients mind again and again in stereotyped form.They are , almost invariably distressing and the patient ofte
Primary outcomes
1
Description
Severity obsessive compulsion
Timepoint
Before the start of trial and every four weeks
Method of measurement
Yale Brown Obsessive -Compulsion Scala
Secondary outcomes
1
Description
Sudden drug effect
Timepoint
Before the start of the trial ,the end of the first-two-fourth-sixth-eighth-twelfth weeks
Method of measurement
Interviwe and examination
Intervention groups
1
Description
In the first intervention group: In addition to SSRIs, it is given ondansetron at an average dose of 8 mg per day for 2 weeks.
Category
Treatment - Drugs
2
Description
In the control group, with SSRIs, the patient will receive the same dose of placebo for 12 weeks as the original drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Clinics of Kashan University of Medical Science
Full name of responsible person
zahra Sepehrmanesh MD
Street address
Ghotbe ravandi Blv. Kargarnejad hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
z.sepehrmanesh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for resaerch Kashan University of Medical Sciences
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Ghotbe ravandi Blv. Kargarnejad hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
z_sepehrmanesh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for resaerch Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zahra sepehrmanesh MD
Position
Assistant professor of child and adolescent psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Ghotbe ravandi Blv. Kargarnejad hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
Z.sepehrmanesh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
kashan University of Medical Science
Full name of responsible person
Zahra Sepehrmanesh MD
Position
Assistant professor of child and adolescent psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Ghotbe Ravandi Blv. Kargarnead Hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
z.sepehrmanesh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Adel MD
Position
Resident in psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ghotbe ravandi Blv. Kargarnejad hospital
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Fax
Email
arush1391@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available