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The study of the efficacy of rivastigmin in cognitive status of schizophrenic patients

Protocol summary

Summary
Schizophrenia, as a major psychiatric disorder is very often associated with cognitive impairments. These impairments include deficits in the process of thinking, attention-precaution, memory function, memory and verbal learning, memory and visual learning, logic and problem solving, and verbal perception. These deficits may lead to reduced social and somatic functions. Of importance is to note to these problems in any treatment programming. Many authors believed that acethyl cholin may play an important role in cognitive processes in human brain and that the reduction of acethyl cholin may result in at least a couple of cognitive symptoms in schizophrenic patients. Rivastigmin, a cholin estrase inhibitor, is an agent which is used in clinical trials aimed at resolving cognitive symptoms. This study is designed to examine the efficacy of rivastigmin in treatment of cognitive symptoms in schizophrenic patients. This is an experimental single-blind study. 30 schizophrenic patients, under treatment with atypical antipsychotic medications are divided in two 15-persons groups. The subject group will receive rivastigmin plus antipsychotics, and the control group will receive placebo and antipsychotics. MMSE questionnair will be used to detect cognitive skills in both groups at two stages: 1) at the beginning of the study, and 2) at 12 weeks later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110083010N3
Registration date: 2012-01-01, 1390/10/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-01, 1390/10/11
Registrant information
Name
Faeze Tatari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 4618
Email address
ftatari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the efficacy of rivastigmin in cognitive status of schizophrenic patients
Public title
The study of the efficacy of rivastigmin in cognitive status of schizophrenic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusive criteria: 1) the diagnosis of schizophrenia made by the psychiatrist based on DSM.IV.TR; 1) the presence of some cognitive deficits; 3) being volunteer to participate in the study; 4) being under treatment with atypical antipsychotic medications. Exclusion criteria: 1) disagreement to participate in the study; 2) treatment with typical antipsychotic agents; 3) absence of any of inclusive criteria; 4) concordance of substance dependence disorders; 5) co-morbidity with organic mental disorders.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ethics committee of Kermanshah University of Medical Sciences and Health Services
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences and Health Services, building no. 2, Shahid Beheshti blvd.
City
Kermanshah
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
٧/٤٢٠/پ

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20-F29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders

Primary outcomes

1

Description
Cognitive status
Timepoint
The week 0 and week 12
Method of measurement
MMSE questionnaire

Secondary outcomes

1

Description
Improvement of cognitive status
Timepoint
The weeks 0 and 12
Method of measurement
MMSE questionnaire

Intervention groups

1

Description
Additive treatment with rivastigmin in intervention group, Rivastigmin 1.5 to 6 mg/ day in one to divided doses.
Category
Treatment - Drugs

2

Description
Addition of placebo instead of rivastigmin in control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences and Heath Services
Full name of responsible person
Fazeh Tatari
Street address
Farabi Hospital, Ashayer Sqare.
City
Kermanshh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences, building no.2, Shahid Beheshti blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Faezeh Tatari
Position
Psychiatrist/Assisstant professor
Other areas of specialty/work
Street address
Farabi Hospital, Ashayer Square.
City
Kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
Email
ftatari@kums.ac.ir , fztatari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah Universiy of Medical Sciences and Health Services
Full name of responsible person
Faezeh Tatari
Position
Psychiatrist/assisstant professor
Other areas of specialty/work
Street address
Farabi Hospital, Ashayer Suare.
City
Kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
Email
ftatari@kums.ac.ir , fztatari@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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