The effect of Memantine on the symptoms of Borderline personality disorder
Design
A clinical trial with a control group, double-blinded, randomized, phase 3 on 40 patients
Settings and conduct
Forty people with BPD are selected and given placebo or memantine orally, depending on which group they belong to. Patient selection and psychological evaluations as well as blood sampling are performed in Iran Psychiatric Hospital. The researcher does not know whether the patient being evaluated belongs to the placebo group or the memantine group. The patients also do not know if they have used placebo or memantine. Drugs and placebos are similar in appearance, such as color, shape, and so on. The patient (placebo or treatment groups) receives the drug in encoded packets. The coding is done by the psychiatrist and the evaluator and the patient are blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women or men between the ages of 16 and 45 who have been diagnosed with BPD using The Best.
Exclusion criteria: Clinical evidence of neurological disorders
Pregnancy or breastfeeding
Intervention groups
40 selected patients are divided into two groups of treatment and control (n = 20)
The treatment group takes 10 mg for the first week, followed by a daily administration of 20 mg of memantine up to the end of week four.
The control group receives a placebo daily during this period.
Main outcome variables
symptoms of the disease; Serum levels of memantine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210106049948N1
Registration date:2021-02-21, 1399/12/03
Registration timing:prospective
Last update:2021-02-21, 1399/12/03
Update count:0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Fariba Karimzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5003
Email address
karimzade.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of memantine on the symptoms of Borderline personality disorder in the Iranian population
Public title
Memantine and borderline personality disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women or men between the ages of 16 and 45 who have been diagnosed with BPD using the BEST tool for the disease.
Exclusion criteria:
Clinical evidence of any pathology in the central nervous system, neurological disorders, head injuries, epilepsy or history of seizures
Pregnancy or breastfeeding
Taking medications that may interact with memantine
Age
From 16 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Following patients' examinations in the Iran Psychiatric Hospital and reviewing the inclusion criteria and eliminating patients who have exclusion criteria, they are divided into two groups by simple randomization, and a code was specified to every patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher does not know whether the patient being evaluated belongs to the placebo group or the memantine group. The patients also do not know if they have used placebo or memantine. Drugs and placebos are similar in appearance, such as color, shape, and so on. The patient (placebo or treatment groups) receives the drug in encoded packets. The coding is done by the psychiatrist and the evaluator and the patient are blind.
Placebo
Used
Assignment
Other
Other design features
There are no unique specifications.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2021-02-03, 1399/11/15
Ethics committee reference number
IR.IUMS.REC.1399.1185
Health conditions studied
1
Description of health condition studied
Borderline personality disorder
ICD-10 code
F60.3
ICD-10 code description
Borderline personality disorder
Primary outcomes
1
Description
Serum levels of memantine
Timepoint
Measurement of serum levels of memantine at the beginning of the study (before the intervention) and at the end of the treatment period
Method of measurement
High Performance Liquid Chromatograpy
2
Description
Symptoms
Timepoint
beginning of the study (before the intervention) and At the end of weeks 2, 4, 6 and 8
Method of measurement
The Best test
Secondary outcomes
1
Description
Number of suicides
Timepoint
At the beginning of the study (before the intervention) and at the end of the intervention
Method of measurement
interview with patients
Intervention groups
1
Description
The placebo group will receive a placebo for 12 weeks. At the end of weeks 2, 4, 6, and 8, BPD symptoms will be evaluated by the Best test. Blood samples will be gathered before the intervention and at the end of the treatment period. Patients take a placebo daily which is made in Iran.
Category
Placebo
2
Description
The treatment group will receive a placebo for 8 weeks. The patients will take 10 mg Memantine daily in week 9. followed by 20 mg Memantine daily from week 10 to 12. At the end of weeks 2, 4, 6, and 8, BPD symptoms will be evaluated by the Best test. Blood samples will be gathered before the intervention and at the end of the treatment period. Memantine is made in Tasnim Darou Company in Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Fariba Karimzadeh
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8670 4725
Email
ّfariba_karimzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Karimzadeh
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4725
Email
fariba_karimzade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fariba Karimzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4725
Email
fariba_karimzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Karimzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4725
Email
fariba_karimzade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Karimzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4725
Email
fariba_karimzade@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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