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IRCT20210106049948N1 IRCT 2021-02-21 Iran University of Medical Sciences Memantine and borderline personality disorder The effect of memantine on the symptoms of Borderline personality disorder in the Iranian population 2021-04-21 anticipated 40 Complete https://irct.ir/trial/53765 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: There are no unique specifications, 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 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. 3 Borderline personality disorder. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Fariba Karimzadeh
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4725 fariba_karimzadeh@yahoo.com Iran University of Medical Sciences scientific Fariba Karimzadeh
Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4725 fariba_karimzade@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Women or men between the ages of 16 and 45 who have been diagnosed with BPD using the BEST tool for the disease. 16 years 45 years Both 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 F60.3 Borderline personality disorder Placebo Treatment - Drugs 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. 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. 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. 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. 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. Iran University of Medical Sciences Approved 2021-02-03 Ethics committee of Iran University of Medical Sciences Cellular and Molecular Research Center, Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)