This open labled RCT research planned in HAZRAT-E-RASOOL hospital rheumatology clinic and executive private clinic, to determine the relation between depression indexes improvment and pain reduction in fibromyalgia patients after duloxetin and pregabalin consumption. The goal of trial is comparison the efficacy of drugs as well as to investigate independent anti-depressant role of duloxetin in reducing pain. 70 Fibromyalgia patients between 18 and 65 years old who have not getting duloxetin, Pregabalin and gabapentin or other antidepressants during the 12 weeks before entering the study will enroll to the study. Patients will randomly be assigned equally in two groups of 35. First, demographic information and sightly questionnaires complete and after dulorimetry one group of patients will take 30 mg duloxetin and the other group will receive 75 mg of Pregabalin. A week later, patients will be visited again and in the absence of significant side effects duloxetin dose will be increased to 60 mg and Pregabalin to 150 mg. Patients will be followed 4 weeks and will be visited again at the end of study to gather outcome variables data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030626935N1
Registration date:2016-07-06, 1395/04/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-06, 1395/04/16
Registrant information
Name
Ali Bidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2202 6576
Email address
bidari.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-08-05, 1395/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Depression and pain improvement in patients with fibromyalgia syndrome with duloxetin or pregsbalin: a comparative open labeled study
Public title
Pregabalin and Duloxetin in fibromyalgia treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: fibromyalgia patients; age between 18 to 65;
Exclusion criteria: receiving Duloxetine, Pregabalin and Gabapentin with other antidepressants during the 12 weeks before entering the study; pregnancy or have a plan to become pregnant during the study; underlying rheumatic disease, cancer, and other diseases that can cause chronic pain which has not been defined in the fibromyalgia syndrome; having a job or duties which need high concentration or alertness; use of MAOI (monoamine oxidase inhibitors) within 14 days before study; chronic liver disease, severe renal failure and uncontrolled narrow-angle glaucoma; history of hypersensitivity to Pregabalin and its components
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Science
Street address
tehran, Hemmat freeway
City
Tehran
Postal code
Approval date
2014-07-21, 1393/04/30
Ethics committee reference number
25371-109861
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Pain
Timepoint
At the begining and 4 weeks after treatment
Method of measurement
FIQ and WPI questionaire
2
Description
Depression
Timepoint
At the begining and 4 weeks after treatment
Method of measurement
SF-12 and becks questionaire
Secondary outcomes
1
Description
Drug adverse reactions
Timepoint
1 week after start the drug
Method of measurement
Drug adverse reactions questionnaire
Intervention groups
1
Description
Duloxetin 30 mg once daily and if tolerate increase to 60 mg once daily for 3 next week.
Category
Treatment - Drugs
2
Description
Pregabalin 75 mg once daily and after 1 week if tolerate increase to 75 mg twice daily for 3 next 3 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumathology clinic of Hazrat Rasool Akram hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Dr Ali Bidari private clinic
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Dr Nahid Kianmehr private clinic
Full name of responsible person
Street address
City
Tehran
4
Recruitment center
Name of recruitment center
Dr Banafsheh Ghavidel private clinic
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Iran University of Medical Sciences
Full name of responsible person
Dr Javad Mousavi
Street address
Hemmat freeway
City
Tehran
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 of Iran 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
Iran University of Medical Science
Full name of responsible person
Dr. Shahrzad Rahmani
Position
Rheumathologist
Other areas of specialty/work
Street address
Firoozgar Hospital
City
Tehran
Postal code
Phone
+98 21 4438 7425
Fax
Email
shz_rahmani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Science
Full name of responsible person
Dr. Ali Bidari
Position
Rheumathologist
Other areas of specialty/work
Street address
Hazrat Rasool Akram Hospital
City
Tehran
Postal code
Phone
+98 21 86701
Fax
Email
bidari.a@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Science
Full name of responsible person
Dr. Shahrzad Rahmani
Position
Rheumatologist
Other areas of specialty/work
Street address
Valiasr square, Firoozgar Hospital
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)