This study is clinical trial double blind (patients and researcher)placebo control that evaluate the efficacy of memantine in treatment of schizophrenia.Criteria for inclusion:age group 18-65 years old;no pregnancy or milking;no mental retardation.Criteria for exclusion: allergy to memantine; drug or substance abuse or dependency. 64 patients with schizophrenia divided into two groups:intervention and control.both of 2 groups receive one atypical anti psychotic, in addition patients in intervention group receive memantin and in control group receive placebo. in intervention group ,memantin start with 5mg per day ,and it's dose increases 5mg weekly ,after 4 weeks,it will be 20 mg per day. clinical assessment perform in baseline and each 4 weeks to 12 weeks,using positive and negative syndrome scale(PANSS),Quality Of Life Scale (QLS),Global Assessment Of Functioning (GAF),Calgary Depressive Scale for Schizophrenia (CDSS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092819320N1
Registration date:2014-11-01, 1393/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-01, 1393/08/10
Registrant information
Name
Maryam Mohammadian Sichani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 9467
Email address
farshid5@sepahan.iut.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Isfahan Univercity of Medical science
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of memantin in improvement of quality of life and global function in patients with schizophrenia
Public title
Effect of memantin in treatment of patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:age group 18-65 ; no mental retardation ;no pregnancy or milking ;diagnosis of schizophrenia for at least 2 years;treatment with atypical anti psychotic from 3 month ago;do not have ECT during 2 week ago
Exclusion criteria:allergic to memantin;addiction or dependency to substance or drugs ;other psychiatric disorder or serious neurological deficit.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Ethics committee of Isfahan Univercity of Medical Sciences
Street address
Isfahan Univercity of Medical Science,Aven Hezar Jerib وIsfahan,IRAN
City
Isfahan
Postal code
Approval date
2013-05-29, 1392/03/08
Ethics committee reference number
392220
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20,F21,F2
ICD-10 code description
Schizophrenia, schizotypal and delusional disorder
Primary outcomes
1
Description
Quality of life
Timepoint
at base line,each 4 weeks to 12weeks
Method of measurement
Quality Of Life scale of schizophrenia
2
Description
Global Function
Timepoint
at baseline,each 4 weeks to 12weeks
Method of measurement
Global Assesment Of Functioning
3
Description
Possitive and negative symptoms
Timepoint
at base line, each 4 weeks to12 weeks
Method of measurement
Possitive And Negative Symptom Scale
4
Description
Depression
Timepoint
at base line,each 4 weeks to12 weeks
Method of measurement
Calgary Depressive Scale for Schizophrenia
Secondary outcomes
1
Description
side effects
Timepoint
during 12 weeks of study
Method of measurement
history of patient and his/her companion and physical exam
Intervention groups
1
Description
control group:placebo tablet that is similar to memantin in shape,size and color. starting with single dose 5mg per day then increase 5mg each week ,up to 10 mg at morning and 10 mg at night after 4 weeks and continuation (10 mg BD)to12 weeks.
Category
Placebo
2
Description
study group : memantine tab,starting with single dose 5mg per day then increase 5mg each week ,up to 10 mg at morning and 10 mg at night after 4 weeks and continue (10 mg BD)to12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Hospital
Full name of responsible person
Mohammadian Sichani Maryam
Street address
Noor Hospital, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan Univercity of Medical science
Full name of responsible person
Dr Ciavash,Manager of Vice chancellor for research of Isfahan Univercity of Medical science
Street address
Isfahan Univercity of Medical Science,Avenue HezarJerib, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Isfahan Univercity of Medical science
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
Isfahan University of Medical Sciences
Full name of responsible person
Mohammadian Sichani Maryam
Position
Resident of Psychiatric
Other areas of specialty/work
Street address
University of medical Sciences, avenue Hezar jeribe, Isfahan, Iran