The purpose of this study was to compare the sertraline vs. extended release venlafaxine in major depression. This randomized clinical trial was performed in Golestan Hospital, Ahvaz. In this study, 34 patients who complained of major depressive disorder were randomly allocated into two groups (16 patients in sertraline group and 18 subjects in venlafaxine group) to receive flexible dose of sertraline or extended release venlafaxine for 4 weeks. Participants should be Fulfilled DSM IV,TR criteria for major depressive disorder and excluded if they were axis I and II comorbidity, suicidal or killing thoughts. Extended-release venlafaxine was initiated with 75 mg and increased 37.5 mg each three days up to 375 mg based on patients' tolerance and response. Sertraline was initiated with 25 mg and increased 25 mg each three days up to 200 mg based on patients' tolerance and response. Depression severity was assessed, through standard Hamilton's depression questionnaire, baseline,before intervention, 2 and 4 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011631626N3
Registration date:2017-03-21, 1396/01/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-21, 1396/01/01
Registrant information
Name
Hatam Boostani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
tabibi.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of efficacy of extended release venlafaxine versus sertraline in treatment of patient with major depression disorder
Public title
comparison of efficacy of extended release venlafaxine versus sertraline in treatment of patient with major depression disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years old;Fulfilled DSM IV TR criteria for major depressive disorder Baseline score 18 on the HDRS 17
Exclusion criteria: Lack of serious health problems including disease axis I and II comorbidity ;
suicidal or killing thoughts ;pregnancy;Severe physical problems and unstable
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done by random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Golestan Hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Postal code
Approval date
2015-04-29, 1394/02/09
Ethics committee reference number
IR.Ajums.REC.1394
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32,F33
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression
Timepoint
before intervention, 2, 4, 6 weeks after treatment
Method of measurement
Hamilton Rating Scale for Depression
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Venlafaxine extended release (75 and 150 mg capsules) at a dose of 75 mg every 3 days starts and are added 37.5 mg.And based on the response and tolerance of side effects, the dose will be increased up to 375 mg.
Category
Treatment - Drugs
2
Description
Intervention group2: Sertraline (100 and 50 mg tablets) starts once daily at a dose of 25 mg and gets added 25 mg every 3 days. And based on the response and tolerance of side effects will increase the dose up to 200 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Hatam Boostani
Street address
Ahvaz Golestan Hospital ,Golestan Blvd,Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam boostani
Street address
Ahvaz Golestan Hospital ,Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
Boostani_h@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
Boostani_h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Amir ali moghadam sadegh
Position
General Practitioner
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences,Golestan Blvd,Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
dr_amiralimoghaddam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)