This double-blind clinical trial, aimed to compare the treatment of patients with moderate depression with fluoxetine versus nortriptyline in the six-month follow-up has been. 90 depressed patients randomly allocated to one of the two groups .Patients in First group have received fluoxetine 60 mg daily for six months and Patients in second group have received nortriptyline 150 mg daily for six months. Assessment tools of Patients were interview, examination and beck test. assessment were performed: at the baseline, three and six months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101155619N1
Registration date:2011-04-12, 1390/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-12, 1390/01/23
Registrant information
Name
Hamid Reza Ghafarian Shirazi
Name of organization / entity
Yasouj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 4850
Email address
ghafarian_h@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasouj University of Medical Sciences
Expected recruitment start date
2007-07-01, 1386/04/10
Expected recruitment end date
2009-07-02, 1388/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fluoxetine versus Nortryptiline in treatment of Depression during six month follow up
Public title
Fluoxetine versus Nortryptiline in treatment of Depression during six month follow up
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : have not used any antidepressant drug before.
Exclusion criteria : not response to treatment after 8 weeks .
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethics committee of Yasouj University of Medical Sciences
Street address
Yasouj University of Medical Sciences
City
Yasouj
Postal code
7193612119
Approval date
2007-08-20, 1386/05/29
Ethics committee reference number
85918-17
Health conditions studied
1
Description of health condition studied
Depressive episode
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression relief
Timepoint
at begining of entrance to the study, three and six month latter
Method of measurement
Interview, clinical examination and Beck test
Secondary outcomes
empty
Intervention groups
1
Description
60mg/ day floxitine vs 150 mg/day nortriptiline for six month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofateh Psychiatric Clinic
Full name of responsible person
Mr Mohamad Malekzadeh
Street address
Montazeri street
City
Yasouj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences and Health Services
Full name of responsible person
Dr Mohamad Zoladl
Street address
Yasouj, Reserch Managment office,
City
Yasouj
Grant name
Grant code / Reference number
p/23/5/2843
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences and Health Services
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
Yasouj University of Medical Sciences
Full name of responsible person
Drt Sied Nazir Hashemi
Position
MD. Specialist Psychiatry
Other areas of specialty/work
Street address
Faculty of Medicine,
City
Yasouj
Postal code
Phone
+98 74 1223 0290
Fax
+98 74 1223 0290
Email
nazir.hashemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences and Health Services
Full name of responsible person
Dr Ali Mohamadi
Position
MD, Assistant Profesor
Other areas of specialty/work
Street address
Faculty of Medicine , Yasouj University of Medical Sciences
City
Yasouj
Postal code
Phone
+98 74 1223 3705
Fax
+98 74 1223 0290
Email
amohammadi@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences and Health Services
Full name of responsible person
Hamid Reza Ghafarian Shirazi
Position
MS Biostatistics, Lecturer, Social Medicine Department
Other areas of specialty/work
Street address
Faculty of Medicine,
City
Yasouj
Postal code
Phone
+98 74 1223 0290
Fax
+98 74 1223 0290
Email
gshr3@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)