The objective of the present study was to explore the efficacy of rivastigmine as an adjunctive medication in PTSD.
A 12 weeks, double-blind, placebo-controlled clinical trial was performed on 36 treatment resistant, PTSD diagnosed subjects aged 30- to 65-year-old. All had the diagnosis for more than 5 years. They were screened to avoid having any cognitive deficits. After obtaining informed consent, usual medication was administered to all participants for a month. Then rivastigmine (up to 6 mg/day) or placebo was gradually added to the ongoing medication in 2 groups and one continued on ongoing treatment randomly. Efficacy of medication was measured by administering PCL-M at baseline and weeks 2, 4, 8, and 12. Collected data were analyzed by appropriate descriptive and analytic statistical tests including ANOVA and Repeated measurement. Reported differences were significant at the 0.05 level or less.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211195280N10
Registration date:2012-12-04, 1391/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-04, 1391/09/14
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
2009-08-23, 1388/06/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of augmentation of rivastigmine in combat post traumatic stress disorder
Public title
Ssurvey of augmentation of rivastigmine in combat post traumatic stress disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusions criteria: PTSD diagnosed based on DSM. IV-TR.military PTSD; MMSE score higher than 25. Exclusion criteria:Case refused . Rivastigmine side effects.
Age
From 30 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
2008-05-28, 1387/03/08
Ethics committee reference number
86578
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder (PTSD)
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder
Primary outcomes
1
Description
Symptoms of PTSD
Timepoint
at baseline and weeks 2, 4, 8, and 12
Method of measurement
PCL-M
Secondary outcomes
empty
Intervention groups
1
Description
rivastigmine 1.5 mg/ day two weeks and after two weeks increased 3mg/day Twice a day .
Category
Treatment - Drugs
2
Description
control group received placebo.
Category
Placebo
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
Amir Rezaei Ardani
Position
assistant
Other areas of specialty/work
Street address
Ebn-e-sina hospital
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
rezaeia@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
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
Amir Rezaei Ardani
Position
assistant
Other areas of specialty/work
Street address
Ebn-e-sina hospital.
City
mashhad
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)