Protocol summary

Study aim
1- Determining the mean score of Y-BOCS in 2 groups of control and drug 2- Determining the average score in 12 weeks after starting the study Comparison of Y-BOCS change in week 0 and 12 between control and drug groups 4- The amount of side effects recorded between the two control and drug groups in week 12
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 22 patients. Excel software rand function was used for randomization. Patients are randomly divided into two groups of drugs and placebo. We prepare the medicine and placebo with the same appearance (including color, size and design) and in the same package with a dose of 50 mg and provide it to the patients.
Settings and conduct
By referring the qualified patients to the office of Dr. Sayyah Bargard, a Psychiatrist, after examining the patient's condition, the drugs were randomly selected and delivered to the patient. All patients were followed up for 12 weeks.
Participants/Inclusion and exclusion criteria
1. People who are recognized as having obsessive-compulsive disorder by the DSM-V standard 2. Has no other mental disorder. 3. Has not been diagnosed with any respiratory disorders. 4. Do not consume alcohol and do not use drugs or stimulants. 5. Be between 18 and 65 years old. 6. The person in question should be treated with SSRI drug for at least 3 months with the maximum dose and has a score of 20 or higher in the Y-BOCS criterion.
Intervention groups
Both groups of patients were told to take one pill every night for 12 weeks, and to report the symptoms of taking the pill by phone or in the attending physician's office. Medication or discontinuation is done.
Main outcome variables
Finding a low-complication and effective drug as adjunctive therapy in refractory obsessive-compulsive disorder.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151103024853N5
Registration date: 2020-11-04, 1399/08/14
Registration timing: retrospective

Last update: 2020-11-04, 1399/08/14
Update count: 0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Leila Kouti
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8379
Email address
kouti-l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
2020-02-29, 1398/12/10
Actual recruitment end date
2020-07-25, 1399/05/04
Trial completion date
2020-07-25, 1399/05/04
Scientific title
Evaluation of Riluzol effect as adjunctive therapy in patients with standard treatment-resistant obsessive-compulsive disorder
Public title
Riluzol effect on treatment of drug resistant obsessive obsessive compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with known obsessive compulsive disorder by DSM-V criteria. Not to use alcohol chronic. The patient had no serious risk factor for respiratory apnea and pulmonary fibrosis and not be affected. Between 18 to 65 years old The individual should be treated with a maximum dose of SSRI for at least 6 months and scored 20 or higher on the Y-BOCS criterion. The patient's liver transaminase should not be more than 5 times higher than normal.
Exclusion criteria:
Pregnancy and nursing; Patients with a history of memantine use. Patients who do not sign the ethical consent form or refuse to continue to participate in the study.
Age
To 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 32
Actual sample size reached: 23
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with 5 blocks will be performed for randomization of the study. The drug and placebo, which are made in exactly the same way, will be placed by the pharmacist unrelated to the research in equal packages of dark medicine with equal number, on the envelope with a label containing the information of the research center, how to use the medicine, patient number, and letters A or B will be placed for the drug group or placebo and the number will be registered in random order. The randomization tool will be statistical software that will be performed by the statistical analyzer of the study. When randomization is performed, each patient receives a code that will be recognized during the study. This code will be from 1 to 32 due to the small number of participants. The process of hiding and grouping patients and the type of medication they receive will not be disclosed to researchers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the drug and the placebo are indistinguishable from the patients and the relevant medical staff because they are exactly the same size, shape and color. The psychiatrist, the researcher recording the patient's condition and the delivery of the drug, and the patient are not aware that the drug received is the main drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Esfand St. Jundishapur University of Medical Sciences School of Pharmacy
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.AJUMS.REC.1398.828

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
patient's score in Y-BOCS test
Timepoint
Before intervention, 4, 8 and 12 weeks after intervention
Method of measurement
the list of Riluzole adverse effects

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Intervention group drug Riluzole 50 mg tablets once a day for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Placebo group 1 tablet daily for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Mohammad hosein Shiveh
Street address
Golestan Hospital, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
golestanjpspital@yahoo.com

2

Recruitment center
Name of recruitment center
private office of Dr Sayyah bargard
Full name of responsible person
Mohammad hosein Shiveh
Street address
Pharmacy School, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
golestanjpspital@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research and technology developement
Full name of responsible person
Nader Saki
Street address
Golestan Blvd., Ahvaz University of Medical Sciences, Vice Chancellor for Research and Technology Development, Ground Floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4695
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology developement
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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad hosein Shiveh
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8379
Email
mohammad.shiveh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Kouti
Position
Clinical pharmacy specialist, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8379
Email
lkouti.pharmacotherapy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Kouti
Position
Clinical pharmacy specialist, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009861337382418
Email
lkouti.pharmacotherapy@gmail.com

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
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