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Evaluation of oral Selenium Sulfide effect on treatment of Refractory Obsessive Compulsive Disorder in a Randomized Double Blind Placebo-Controlled Clinical Trial

Protocol summary

Study aim
Evaluation of oral Selenium Sulfide effect on a Refractory Obsessive Compulsive Disorder
Design
Placebo-controlled, parallel groups, double blind, randomized (with random numbers table), phase 3 Clinical Trial
Settings and conduct
In this study patients are divided randomly to two intervention and control groups. intervention group are given fluoxetine 20 mg plus selenium 200 mcg once a day and control group are given fluoxetine 20 mg plus placebo once a day for 6 week. Psychiatrist and patient did not know about groups. study done in ahvaz bardia psychiatry clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 62 years, Minimum score of Yale brown questionnaire should be 21, Obtaining written informed consent before entering into the study. Exclusion criteria: Pregnancy, Internal diseases (diabetic patients, hypertension &...), Psychotic patient and mood disorders and neurology diseases, Thinking about suicide, Addiction to alcohol and narcotics, IQ below 80
Intervention groups
Intervention group: Included patients suffer from Obsessive Compulsive Disorder use Selenium Sulfide capsule 200 mcg(manufactory: century, made in USA), once a day, for 6 weeks plus Fluoxetine capsule 20 mg(manufactory: Abidi, made in Iran), once a day, for 6 weeks. Control group: Included patients suffer from Obsessive Compulsive Disorder use placebo capsule(manufactory: Pharmaceutical Technology Development Center of Ahvaz Jundishapur University of Medical Sciences), once a day for 6 weeks plus Fluoxetine capsule 20 mg(manufactory: Abidi, made in Iran), once a day for 6 weeks.
Main outcome variables
Scale of Obsession and Copmpulsion disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180212038699N1
Registration date: 2018-05-04, 1397/02/14
Registration timing: retrospective

Last update: 2018-05-04, 1397/02/14
Update count: 0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Mina Andishmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 1298
Email address
andishmand.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-04-16, 1397/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral Selenium Sulfide effect on treatment of Refractory Obsessive Compulsive Disorder in a Randomized Double Blind Placebo-Controlled Clinical Trial
Public title
Evaluation of oral Selenium Sulfide effect on treatment of Refractory Obsessive Compulsive Disorder in a Randomized Double Blind Placebo-Controlled Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 62 years Minimum score of Yale brown questionnaire should be 21 Obtaining written informed consent before entering into the study use fluoxetine 20 mg once a day
Exclusion criteria:
Pregnancy Internal diseases (diabetic patients , hypertension & ...) Psychotic patients and mood disorders and neurology diseases Thinking about suicide Addiction to alcohol and narcotics IQ below 80
Age
From 18 years old to 62 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researcher both are blind
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd, Ahvaz Jundishapur University of Medical Sciencesmedical sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.AJUMS.REC.1396.930

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
Obsession and compulsion score in Yale–Brown Obsessive Compulsive Scale (Y-BOCS)
Timepoint
measurement yale brown questionnaire score in the began of first week and in the end of sixth week
Method of measurement
yale brown questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Included patients suffer from Obsessive Compulsive Disorder use Selenium Sulfide capsule 200 mcg (manufactoty: Century, made in USA) once a day for 6 weeks plus Fluoxetine capsule 20 mg (manufactory: Abidi, made in Iran) once a day, for 6 weeks.
Category
Treatment - Drugs

2

Description
Control group: Included patients suffer from Obsessive Compulsive Disorder use placebo capsule (Manufactory: Pharmaceutical Technology Development Center of Ahvaz Jundishapur University of Medical Sciences) once a day, for 6 weeks plus Fluoxetine capsule 20 mg (manufactory: Abidi, made in Iran) once a day for 6 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک روانپزشکی بردیا
Full name of responsible person
دکتر مهدی سیاح برگرد
Street address
East Mihan Ave, Kianpars Blvd, Jordan Physicians Town, First Floor
City
Ahvaz
Province
Khouzestan
Postal code
6136946731
Phone
+98 61 3336 8801
Email
sayahbargard@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Sayah Bargard
Street address
Ahvaz jundishapur university of medical sciences, Golestan boulvard
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Fax
+98 61 3336 1544
Email
andishmand.m@ajums.ac.ir
Web page address
htpp://www.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Sayah Bargard
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan blvd, Ahvaz jondishapur university of medical sciences, Collage of hygine, second floor, EDC office
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
sayahbargard@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Andishmand
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Farhang 2 Ave, golestan Blvd, Negin 5 Town, Unit 14
City
Ahvaz
Province
Khouzestan
Postal code
6136956731
Phone
+98 61 3374 1298
Email
andishmand.m@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Andishmand
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Farhang 2 Ave, Golestan Blvd, Negin 5 Town, Unit 16
City
Ahvaz
Province
Khouzestan
Postal code
613695731
Phone
+98 61 3374 1298
Email
andishmand.m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information related to main consequences can be share
When the data will become available and for how long
access beganning will be 2 month after publish
To whom data/document is available
Medical sciences and health researchers
Under which criteria data/document could be used
All analytical tests can be done
From where data/document is obtainable
Mina Andishmand, andishmand.m@ajums.ac.ir, 09163227484 Mehdi Sayah Bargard, Sayah_bargard@aol.com, 09126348518
What processes are involved for a request to access data/document
one week after demand decuments will be given to applicant
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