1) Objectives: Sertraline effectiveness in prevention of depression, fatigue reduction and QOL improvement in MS patients.
2) Design: Double- blinded,randomized clinical trails.
3)Setting and conduct : The patients with multiple sclerosis from neurology clinic of Razi hospital were referred to our study by neurologist will be divided into two groups,intervention and control .
4)Participants: The patients with multiple sclerosis from neurology clinic of Razi hospital with inclusion criteria(Age 15-60;Primary education) and exclusion criteria(Other Organic illnesses:Other mental disorder;Smoking and substance induce or alcohol abuser) were referred to our study by neurologist .
5)Intervention : Sertralin 50 mg daily in intervention group and placebo daily in control group .
6) Main outcomes measurement variables:Depression, Fatigue, Quality Of Life .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090723927N1
Registration date:2015-11-02, 1394/08/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-02, 1394/08/11
Registrant information
Name
Mohammad Askarpour
Name of organization / entity
Tabriz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 41 3660 7265
Email address
askarpour@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz university of medical science.
Expected recruitment start date
2015-09-21, 1394/06/30
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sertraline effectiveness in prevention of depression, fatigue reduction and QOL improvement in MS patients.
Public title
Sertraline effectiveness in prevention of depression in MS patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
Age 15-60;Primary education Exclusion;
Other Organic illnesses:Other mental disorder;Smoking and substance induce or alcohol abuser.
Age
From 79 years old to 34 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
------
Secondary trial Id
--------
Registration date
empty
2
Registry name
------------
Secondary trial Id
--------
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Flour 3, Building 2, Golgasht Av, Tabriz university of medical science
City
Tabriz
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
TBZMED.REC.1394.493
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Depresion
Timepoint
Atfirst of study, 1 mth later, 3mth later, 6 mth later
Method of measurement
Hamilton Questionnaire
2
Description
Decreament OF Fatigue
Timepoint
Atfirst of study, 1 mth later, 3mth later, 6 mth later
Method of measurement
SF_36 Questionnaire
3
Description
Quality of life
Timepoint
Atfirst of study, 1 mth later, 3mth later, 6 mth later
Method of measurement
FSS Questionnaire OF QOL
Secondary outcomes
1
Description
Probably switch to mania.
Timepoint
During fallow up times.
Method of measurement
Based on DSM criteria.
Intervention groups
1
Description
In study group we will add 50 mg sertraline produced by sobhan manufacture every day for six months,this group will consider at the beginning ,end of 1th month, 3th month and end 6th month for depression symptoms.
Category
Prevention
2
Description
In control group we will add one placebo produced by pharmacy faculty of Tabriz university of medical science for six months every day . They will consider at the beginning , end of 1th month ,3th month and end of 6th month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Shaafi(Associate professor)Dr Hashemilar(Associate professor)