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IRCT20201227049851N1 IRCT 2021-03-07 Kashan University of Medical Sciences "Efficacy of Memantine Add on Treatment in Obsessive Compulsive Disorder" Efficacy of Memantine augmentation in moderate to severe obsessive-compulsive symptoms 2021-03-15 anticipated 30 Complete https://irct.ir/trial/54141 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning treatment is permuted block randomization with quadruple blocks according to the random number table . Thus, by collecting each qualified quadruple block, one of the serials AABB, ABAB, BAAB, BABA, BBAA, ABBA is randomly assigned to the items within each block. The serials were made according to the permutation formula P (x, y, z) = P (x) × P (Y) × P (Z), which for a block of 4, the number of permutations of the possible combination is 4! /2 !× 2 != 6 was obtained and probable sequences were made to its number based on it .Consequently, according to the so called instructions, the patient will be stratified into one of the groups A or B. The drugs prepared under the label A or B are mixed in a carton and provided to the project implementers, Blinding description: The placebo prepared by Kashan University of Medical Sciences and the memantine tablet produced by Darupakhsh Company are prepared in the similar gelatin capsule coating in terms of appearance, size and color and taste, in matched and sealed packages. Sertraline produced by Sobhan Daroo Company is also provided by the project executors given to the patients. Drug distribution is done by a staff member of the clinic of Kargarnezhad Hospital who has not participated in any of the steps of preparation, packaging and coding. The distribution of medicine is done in 0,1,2 weeks and then once every two weeks at the so-called clinic. 3 Obsessive-compulsive disorder. Intervention 1: Intervention group :15 male and female patients between the ages of 18 and 60 years who have moderate to severe obsessive-compulsive disorder based on DSM V-based clinical interview and Yale Brown test score will be treated with treated with Sobhan Daru Company's Sertraline tablets and Daroo Pakhsh Memantine tablets. Sertraline tablets will be started with a daily dose of 50 mg and the dose is increased 50 milligrams every week up to 200mgs and continued until the end of the eighth week. Memantine tablets in a placebo-like gelatin coating will be started at 5 mg daily and increased to 10 mg daily at the end of the first week and continued at the same dose until the end of week 8. Patients will be visited in weeks 0, 1, 2, 4, and 8 and the Yale Brown questionnaire and the side effects checklist will be completed. Intervention 2: Control group: 15 male and female patients between 18 and 60 years of age with moderate to severe obsessive-compulsive disorder according to a DSM V based clinical interview and a Yale Brown questionnaire will be treated with Sertraline tablets of Sobhan Daru Company and the placebo prepared by Kashan University of Medical Sciences in similar gelatin capsule coatings for 8 weeks. Sertraline tablets produced by Sobhan Daru Company will be initiated with a dose of 50 mgs. The dose will be increased by 50 mgs every week up to 200 mg until the end of week 8. At the same time, patients will receive a placebo( Darupakhsh 1 mg tablet) containing gelatin capsule once a day from week 0 to the end of week 8.They will be visited in weeks 0, 1, 2, 4, and 8 and the Yale Brown questionnaire and the side effects checklist will be completed at weeks 0,2,4,8. Yes - There is a plan to make this available What will be shared: Demographic characteristics of subjects, raw scores of Yale Brown tests, checklist of side effects When: Access period starts one year after the results are published To whom: Researchers working for academic and scientific institutes Conditions: For metanalyses and systematic reviews and head to head studies Where to obtain: Research Center of the Vice Chancellor for Research of Kashan University of Medical Sciences How to obtain: Sending a request letter to the Vice Chancellor for Research of Kashan University of Medical Sciences approved by the supervisor attending of the project Comments:
public Atefeh Sattarinezhad
Kargarnezhad hospital ,Qotb Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8715973446 +98 31 5554 9111 sattarinezhad-a@kaums.ac.ir Kashan University of Medical Sciences scientific Zahra Sepehrmanesh
Kargarnezhad hospital,Qotb Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8715973446 +98 31 5554 9111 sepehrmanesh_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) All patients who suffer from obsessive-compulsive disorder according to DSM V and clinical interview. Patients who have Yale-Brown Scores of 15 and above. Patients who give written consent for participating in the study. 18 years 60 years Both Patients who are diagnosed with a comorbid DSM V psychiatric diagnosis. Patients who suffer from any systemic disease such as diabetes, hypo and hyperthyroidism,hypertension,hepatic failure or renal failure. Patients who use alcohol or any other substance. Patients who have received a psychotropic medicine during the last 6 months. Women who are pregnant or breastfeeding or do not use any certain contraceptive method. Patients who use concomitant somatic treatments. Patients who are under treatment with Acetyl Cysteine, buprenorphine or any other medicine Patients who receive any kind of psychotherapies. F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Intervention group :15 male and female patients between the ages of 18 and 60 years who have moderate to severe obsessive-compulsive disorder based on DSM V-based clinical interview and Yale Brown test score will be treated with treated with Sobhan Daru Company's Sertraline tablets and Daroo Pakhsh Memantine tablets. Sertraline tablets will be started with a daily dose of 50 mg and the dose is increased 50 milligrams every week up to 200mgs and continued until the end of the eighth week. Memantine tablets in a placebo-like gelatin coating will be started at 5 mg daily and increased to 10 mg daily at the end of the first week and continued at the same dose until the end of week 8. Patients will be visited in weeks 0, 1, 2, 4, and 8 and the Yale Brown questionnaire and the side effects checklist will be completed. Control group: 15 male and female patients between 18 and 60 years of age with moderate to severe obsessive-compulsive disorder according to a DSM V based clinical interview and a Yale Brown questionnaire will be treated with Sertraline tablets of Sobhan Daru Company and the placebo prepared by Kashan University of Medical Sciences in similar gelatin capsule coatings for 8 weeks. Sertraline tablets produced by Sobhan Daru Company will be initiated with a dose of 50 mgs. The dose will be increased by 50 mgs every week up to 200 mg until the end of week 8. At the same time, patients will receive a placebo( Darupakhsh 1 mg tablet) containing gelatin capsule once a day from week 0 to the end of week 8.They will be visited in weeks 0, 1, 2, 4, and 8 and the Yale Brown questionnaire and the side effects checklist will be completed at weeks 0,2,4,8. Yale Brown Score. Timepoint: Weeks 0,2,4,8. Method of measurement: Yale Brown Scale questionnaire. Kashan University of Medical Sciences Approved 2021-02-24 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences,Qotb Ravandi Blvd. Kashan Isfehan Iran (Islamic Republic of)