Objective: The aim of this study was to evaluate the effectiveness of Pregabalin augmentation to antidepressant treatment (Selective Serotonin Reuptake Inhibitors and Sodium valproate) in patients with chronic posttraumatic stress disorder (PTSD). Methods: This was a double-blinded placebo-controlled clinical trial conducted at Ibn-E-Sina Hospital (Mashhad, Iran) at 2013. 37 male patients diagnosed with PTSD based on DSM-IV-TR criteria were randomly allocated to two groups. The case group (18 patients) received Pregabalin (300 mg/day) and stable doses of antidepressants and the control group (19 patients) received placebo and routine treatment for 6 weeks. Assessments were done at baseline; two, four and six weeks based on PTSD Check List–Military version (PCL-M), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale and Spitzer quality of life index.
Inclusion criteria: diagnose with PTSD based on DSM-IV-TR criteria and sensitivity to Pregabalin and active medical disease were Exclusion criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302145280N12
Registration date:2013-08-30, 1392/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-30, 1392/06/08
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of Pregabalin augmentation in patients with chronic post traumatic stress disorder
Public title
Survey of Pregabalin augmentation in patients with chronic post traumatic stress disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnose with PTSD based on DSM-IV-TR criteria, age between 30 and 65 years, had no significant cognitive disorder and no history of drug abuse except for nicotine.
Exclusion criteria: were unwillingness of patients to continue the trial; active medical disease, other diseases in axis one or two except for PTSD and sensitivity to Pregabalin.
Age
From 35 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreish building, Daneshgah Street.
City
Mashhad
Postal code
Approval date
2011-11-26, 1390/09/05
Ethics committee reference number
900441
Health conditions studied
1
Description of health condition studied
chronic Post-traumatic stress disorder( PTSD)
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder
Primary outcomes
1
Description
Post traumatic stress disorder
Timepoint
0, 2, 4 and 6th weeks
Method of measurement
PCL test
Secondary outcomes
1
Description
Quality of life
Timepoint
0, 2, 4 and 6th weeks
Method of measurement
Spitzer Quality of Life index( SQL)
2
Description
Depression
Timepoint
0, 2, 4 and 6th weeks
Method of measurement
Hamilton Depression Rating Scale
3
Description
Anxiety
Timepoint
0, 2, 4 and 6th weeks
Method of measurement
Hamilton Anxiety Rating Scale
Intervention groups
1
Description
The case group received SSRI( Serteraline 50-200 mg or citalopram 20-40 mg) daily for 6 weeks. received Pregabalin (75 mg/day for the first week then 75 mg twice daily for the second week and continued with 150 mg twice daily from the third week to the sixth week) .
Category
Treatment - Drugs
2
Description
control group received placebo and routine treatment daily for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn-e- sina hospital
Full name of responsible person
Street address
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ardakanian Marjan
Street address
Ghoreish building,Daneshgah street.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahdi Baniasadi
Position
MD
Other areas of specialty/work
Street address
Ebn-e-sina hospital. hore ameli blv.
City
Mashhad
Postal code
Phone
+98 51 1711 2721
Fax
Email
mehdi.baniasadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Fayyazi Bordbar
Position
Associate Professor
Other areas of specialty/work
Street address
Ibn-E- Sina Hospital
City
mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
fayyaziMr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahdi Bniasadi
Position
MD
Other areas of specialty/work
Street address
Ebn-e-sina hospital, hore ameli blv.
City
Mashhad
Postal code
Phone
+98 51 1711 2721
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)