Protocol summary

Summary
this double-blind randomized clinical trial is performed on adults who are referred to the psychiatry outpatient clinics of Shahid Sadughi University of Medical Science. A convenience sample of 50 patients of both genders aged 18-54 years is entered in this study. Participants are included in this study if they fulfill the criteria of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)., and we use the 17-item Hamilton Depression Rating Scale (HDRS). Patients with other mental illnesses, such as severe major depression, , bipolar disorder or anxiety-, alcoholic or drug abuse patients,patients with other significant medical diseases ,psychotic patients, pregnant women and breastfeeding mothers,and patients who had been treated with any antidepressants within 4 weeks before the study are excluded. the patients should be medically stable. Using simple randomization, patients who meet all criteria for enrollment are randomly allocate into 2 treatment groups. Both patients and psychiatrist are blinded to the type of treatment.citalopram is commenced with the initial dose of 10 mg daily,and gradually increases to 40 mg daily.venlafaxine ER starting dose is 37.5 mg daily,then gradually increases to 150 mg a day.f0llow up visits is every a 2 weeks for 8 weeks.we ask patients about any possible side effects, and calculated a HDRS total score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203048513N1
Registration date: 2014-07-09, 1393/04/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-09, 1393/04/18
Registrant information
Name
Fariba Amini
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 2623 3857
Email address
f_amini_1974@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi University of Medical Scieence
Expected recruitment start date
2012-04-09, 1391/01/21
Expected recruitment end date
2012-09-11, 1391/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Venlafaxine versus Citalopram in treatment of acute phase of major depression disorder
Public title
Venlafaxine versus Citalopram in treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria :mild to moderate major depressive disorder ; patients with primary depression or with any symptom in a month ago exclusion criteria : severe depression ;bipolarity ; anxiety disorder ; alcoholic or drug abuse ; patients with other significant medical diseases ; psychotic disorder ; pregnant women and breast feeding mothers
Age
From 18 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 53
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadughi University of Medicai Siense
Street address
Safaieh , Yazd
City
Taft
Postal code
8991683416
Approval date
2012-02-06, 1390/11/17
Ethics committee reference number
142163

Health conditions studied

1

Description of health condition studied
Major depressive disorder
ICD-10 code
F32.0 ,F32
ICD-10 code description
Mild depressive episode , Moderate depressive episode

Primary outcomes

1

Description
level of recovery of depression
Timepoint
before of study & follow up visits every a 2-weeksfor 8 weeks.
Method of measurement
cheking of hamilton score

Secondary outcomes

1

Description
side effect of drugs
Timepoint
every 2 weeks for 8 weeks
Method of measurement
with history taking & blood pressure cheking

Intervention groups

1

Description
average 25 patients are randomized in this group.citalopram is commenced with the initial dose of 10 mg daily, and gradually increases to 40 mg daily.this study lasts 8 weeks and we collect patients information including Hamilton Depression scale very a 2 weeks.on each follow up visits ,we ask patients about possible adverse effects and complete its questionnaires.
Category
Treatment - Drugs

2

Description
average 25 patients are randomized in this group.venlafaxine starting dose is 37.5 mg daily , then gradually increases to 150 mg daily.this study lasts 8 weeks and we collect patients information including Hamilton Depression scale very a 2 weeks.on each follow up visits ,we ask patients about possible adverse effects and complete its questionnaires.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
psychiatry outpatient clinics of yazd university
Full name of responsible person
Dr.fariba amini
Street address
taft.psychiatry hospital
City
taft

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadughi University of Medical Science
Full name of responsible person
Research Assistant
Street address
Safaieh , Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadughi University of Medical Science
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
Shahid Sadughi University of Medical Science
Full name of responsible person
Dr.fariba amini
Position
residente of psychiatry
Other areas of specialty/work
Street address
safaieh, Yazd
City
Yazd
Postal code
Phone
+98 38 1334 6898
Fax
Email
f_amini_1974@yahoo.com ,f_amini_1974@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadughi University of Medical Science
Full name of responsible person
Dr.fateme hosseini
Position
Psychiatrist
Other areas of specialty/work
Street address
Yazd
City
Yazd
Postal code
Phone
+98 35 2623 2006
Fax
Email
hosseini.k.f@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadughi University of Medical science
Full name of responsible person
Dr.fariba amini
Position
resident of psychiatry
Other areas of specialty/work
Street address
Yazd
City
Taft
Postal code
۰۰۹۸۳۸۱۳۳۴۶۸۹۸
Phone
Fax
Email
f_amini_1974@yahoo.comf_amini_1974@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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