This trial is going to survey effect of nicotine on visuospatial cognition in schizophrenic patients. Forty five cigarette smoker patients are selected from Tabriz Razi hospital and randomly assigned into one of 3 equal groups. At the baseline, patients are tested by visuospatial memory test on admission; then they are grouped into 3 group on discharge. First group will be tested without any intervention and after smoking their cigarettes. Seccond group will be tested before smoking cigarette in the morning. Third group will be tested after administering 15 mg nicotine patches in the morning. Visuospatial cognition ismeasured as primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903142999N2
Registration date:2010-06-18, 1389/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-18, 1389/03/28
Registrant information
Name
Alireza Farnam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5951
Email address
farnama@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of nicotine on visuospatial deficits in schizophrenia
Public title
Effect of nicotine on cognition of schizophrenics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 to 40 years, less than 2 years from the start of disease course, being able to cooperate testing
Exclusion criteria: Coexistence of another major psychopathology such as mood or cognitive disorders or mental retardation, Non smoker patients
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
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
Ethic committee, Tabriz University of Medical Sciences
Street address
Univeristy Ave.
City
Tabriz
Postal code
Approval date
2010-06-24, 1389/04/03
Ethics committee reference number
896
Health conditions studied
1
Description of health condition studied
schisophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
visuospatial test score
Timepoint
before treating the acute phase, after treating acute phase at discharge
Method of measurement
BVMT-R(Breaf Visuospatial Memory Test-Revised)
Secondary outcomes
empty
Intervention groups
1
Description
First group will be tested without any intervention and after smoking their cigarettes.
Category
N/A
2
Description
Seccond group will be tested before smoking cigarette in the morning
Category
N/A
3
Description
Third group will be tested after administering 15 mg nicotine patches in the morning
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr Faramarz Ghiasi
Street address
Razi hospital, Elgoli ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr farnam, Alireza.
Street address
Tabriz University of Medical Sciences, Daneshgah street,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Faramarz Ghiasi
Position
Psychiatry Assistant
Other areas of specialty/work
Street address
Elgoli ave, Razi Hospital.
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
ghiasifaram@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Farnam
Position
Assistant professor
Other areas of specialty/work
Street address
Razi hospital, Elgoli ave,
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
alirezafanam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Faramarz Ghiasi,
Position
Psychiatry assistant
Other areas of specialty/work
Street address
Razi hospital, Elgoli ave.
City
Tabriz
Postal code
00984113804486
Phone
Fax
Email
ghiasifaram@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)