Objectives: This study aimed at evaluating the efficacy of complementory use of memantine in treatment of schizophrenia with chronic course
Design: Clinical trial study
Setting and conduct: Clinical trial study in educational center
Participants including major eligibility criteria: Sixty patients with chronic schizophrenic will be evaluated. Schizophrenic patients are randomly divided into two groups.
Intervention: The first group will be treated with oral Risperidone 6 mg per day and 5-20 mg Memantine (n=30) and the other group will be received Risperidone 6 mg per day and placebo (n = 30).
Main outcome: Change drastically from week zero to week 8 based on the Positive and Negative Scale will be measured. Patients will be evaluated in regard of extrapyramidal side effects and complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306015605N1
Registration date:2013-10-19, 1392/07/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-19, 1392/07/27
Registrant information
Name
MOHAMAD GOLDUST
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133614711
Email address
medres@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Clinical psychiatry research center, Tabriz university of medical sciences
Expected recruitment start date
2012-11-20, 1391/08/30
Expected recruitment end date
2013-11-20, 1392/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of complementory use of memantine in treatment of schizophrenia with chronic course
Public title
The efficacy of complementory use of memantine in treatment of schizophrenia with chronic course
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:
Substance abuse; IQ of less than 70; Medical history of other mental disorder; Other clinical and neurological disorders; Taking antipsychotic medications during last week or long acting antipsychotic medications during past month; Receiving ECT in the past two weeks; Sensitivity to Memantine
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz university of medical sciences
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
91147
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Schizophrenia severity
Timepoint
6 monthes
Method of measurement
Clinical assesment
Secondary outcomes
1
Description
Side effects
Timepoint
Two month after begining of the study
Method of measurement
Clinical assessment
Intervention groups
1
Description
The control group will be received Risperidone 6 mg per day and placebo (n = 30).
Category
Treatment - Drugs
2
Description
The case group will be treated with oral Risperidone 6 mg per day and 5-20 mg Memantine (n=30)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of psychiatrics, Razi hospital
Full name of responsible person
Dr Ali Fakhari
Street address
5166614711, El goli street, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Clinical psychiatry research center, Tabriz university of medical sciences
Full name of responsible person
Ali Fakhari
Street address
5166614711, El goli street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Clinical psychiatry research center, 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 Ashkan Yousefi
Position
Resident in Psychiatrics
Other areas of specialty/work
Street address
5166614711, El goli street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
Drmgjgoldust@gmail.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 Ali Fakhari
Position
Associate professor in psychiatrics
Other areas of specialty/work
Street address
5166614711, El goli street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
fakharia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)