Effect of memantine on the improvement of cognitive symptoms in schizophrenic patients
Design
Clinical trial with community-based and pragmatic control group, with parallel, double-blind, randomized,
Settings and conduct
Patients were randomly divided into two groups of memantine and placebo recipients (randomized tables). Patients received medication in Avicenna and Hejazi hospitals in Mashhad.
Participants/Inclusion and exclusion criteria
1) Schizophrenia in the relative recovery period
2) aged 18 to 60 years
Intervention groups
In the memantine group, patients started a daily dose of 5 mg memantine, which increased the dose by 5 mg weekly to reach 20 mg / day (in two doses).
In the placebo group, the placebo was similar to memantine, according to the same protocol.
Main outcome variables
Changes in psychotic symptoms, cognitive symptoms, extrapyramidal side effects and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180301038906N1
Registration date:2018-06-10, 1397/03/20
Registration timing:retrospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Najmeh Shahini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3215 5653
Email address
shahinin921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2018-05-08, 1397/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adjunctive Memantine Therapy for Negative Symptoms in Schizophrenia: A Double-Blind Placebo Controlled Study
Public title
adding memantine to treatment of schozopherenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Schizophrenia in the relative recovery period
Use of atypical antipsychotics including risperidone and olanzapine
No other drugs (except anticholinergic and benzodiazepine)
Lack of pregnancy or breastfeeding
No serious organic disease and no drug use at the time of entering the study
Exclusion criteria:
There is serious organic disease
Pregnancy or breastfeeding
Existence of dementia
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Computerized table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, the method of blindness is as follows, and all of the following are blind to intervention.
The doctor and the people who take care of the patients
A resident who collects data
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Ibn Sina Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
4915773335
Approval date
2015-03-03, 1393/12/12
Ethics committee reference number
IR.MUMS.fm.REC.1390.11
Health conditions studied
1
Description of health condition studied
schizopherenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
The condition of psychotic symptoms
Timepoint
Week 2,4,6
Method of measurement
wechsler
Secondary outcomes
1
Description
cognitive and negative symptoms
Timepoint
week 2,4,6
Method of measurement
wechsler
Intervention groups
1
Description
Intervention group: For patients, a daily dose of 5 mg of memantine was started, with a dose of 5 mg a week to reach 20 mg / day (in two doses)..Patients in both groups "had an atypical antipsychotic drug, including risperidone and olanzapine.
Category
Treatment - Drugs
2
Description
Control group: For patients, a daily dose of 5 mg of memantine was started, with a dose of 5 mg a week to reach 20 mg / day (in two doses).Patients in both groups "had an atypical antipsychotic drug, including risperidone and olanzapine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital
Full name of responsible person
raheleh jahantigh
Street address
hore ameli
City
mashhad
Province
Razavi Khorasan
Postal code
4915773335
Phone
+98 51 3711 2722
Email
pr.mohammadreza.fayyazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
raheleh jahantigh
Street address
hore ameli
City
mashhad
Province
Razavi Khorasan
Postal code
4915773335
Phone
+98 51 3711 2722
Email
pr.mohammadreza.fayyazi@gmail.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Jahantigh
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hore ameli
City
Mashhad
Province
Razavi Khorasan
Postal code
4915773335
Phone
+98 989157030782
Email
MohammadzadehA931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Jahantigh
Position
psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hore ameli
City
Mashhad
Province
Razavi Khorasan
Postal code
4915773335
Phone
+98 51 3711 2722
Email
MohammadzadehA931@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Jahantigh
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
hore ameli
City
Mashhad
Province
Razavi Khorasan
Postal code
123456789
Phone
+98 123456789
Email
MohammadzadehA931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available