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IRCT20140120016280N4 IRCT 2020-07-30 Tehran University of Medical Sciences Evaluation of Memantine’s Effect on Symptom Characteristics in Patients with Obsessive Compulsive Disorder Evaluation of Memantine’s Effect on Symptom Characteristics, Neuro-Cognitive Functioning and Neuronal Networks Organization in Patients with Obsessive-Compulsive Disorder: A Randomized, Double-blind, Placebo-Controlled Clinical Trial with Parallel Design 2020-09-10 anticipated 48 Complete https://irct.ir/trial/43566 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization process will be done using permuted block randomization with blocks in size 4. Regarding determined sample size 48و, quadratic blocks will be produced using the online website: www.sealedenvelope.com. Unique code will be used to apply the allocation concealment to drug boxes, and the code will also be generated by the software. As each individual enters the study based on the sequence generated, the drug box in which the code in question is assigned will be assigned to the individual, Blinding description: Since the current study will be performed within the neuropsychiatry context and the probability of bias and placebo effects are considerable, the subjects and the main investigator, the assessor, would be blinded. Therefore, the primary general evaluations, neuropsychological assessments, and patient preparation for neuroimaging will be executed by a trained clinical psychologist, based on a table that every subject has a distinct code. Staff responsible for preparing trial medications and the randomization process will not be further involved in the study. 3 Obsessive Compulsive Disorder (OCD). Intervention 1: Intervention group: This group, which includes subjects with a diagnosis of obsessive-compulsive disorder, will receive memantine hydrochloride (C12H21N•HCl) 10 mg twice daily in two 8-week phases (total sixteen weeks). Memantine, a non-competitive glutamate receptor antagonist, is used to treat moderate to severe Alzheimer's disease. Memantine blocks the effects of sustained and elevated levels of glutamate, which can impair neuronal function. In addition, memantine provides the conditions for increased expression of the N-methyl-diaspartate receptor gene, which causes glutamate to act at higher concentrations and actually increase the threshold. Memantine has also shown a negligible affinity for gamma-aminobutyric acid, benzodiazepine, dopamine, adrenergic, histamine, glycine and voltage-dependent receptors for calcium, sodium, or potassium. Memantine is well absorbed from the gastrointestinal tract and is linear in its therapeutic dose range. It is essentially excreted by the kidneys and unchanged in urine and has a terminal half-life of about 60 to 80 hours. Intervention 2: Control group: This group, which includes subjects with a diagnosis of obsessive-compulsive disorder, will receive placebo of memantine twice daily for two 8-week stages (total sixteen weeks). Yes - There is a plan to make this available What will be shared: Information of the main (primary outcome) and the secondary outcomes like neurocognitive functioning and neuronal networks reorganization outcome could be shared. When: 6 months after publication of results To whom: Research data will be available for the researchers of universities and scientific institutes and also relevant investigators of the industries. Conditions: The data will be available, when the samples are taken out, all the stages of the project are completed and finalized, and the results are published. Where to obtain: 1. Dr Mahmoudreza Hdjighassem First Address: Neuroscience Group, Reihaneh Department, Keshavarz BLVD, Imam Khomeini Hospital Complex. Tehran. Second Address: 87, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran. Cell Phone Number: 09126779102 Faculty Phone Number: 02143052000 Fax Number: 02188991117 Email Address: mhadjighassem@tums.ac.ir 2. Lida Shafaghi Address: 87, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran. Cell Phone Number: 09123832340 Fcaulty Number: 0214305200 Email Address: Lidashafaghi@gmail.com How to obtain: In order to receive the information, firstly the applicants send the formal application to the correspondent of the present proposal, Dr. Hadjighassem (Associate Professor of the Department of Neuroscience and Addiction studies, School of Advanced Technologies in Medicine) and then they will be informed of the details of the data reception (including timing-that will be tried to be within the shortest possible interval- and the way of the addressing the available data like email or in person. Comments:
public Mahmoudreza Hadjighassem
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
Tehran Iran (Islamic Republic of) 1417755469 +98 02143052000 , +98 02188991102 mhadjighassem@tums.ac.ir Tehran University of Medical Sciences scientific Mahmoudreza Hadjighassem
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
Tehran Iran (Islamic Republic of) 1417755469 +98 02143052000 , +98 02188991102 mhadjighassem@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive diagnosis of obsessive-compulsive disorder based on the psychiatrist assessment and its confirmation according to SCID-5 (Structured-Clinical Interview for DSM5) by the clinical psychologist Y-BOCS Score equal or more than 16 for obsessions and compulsions or equal or more than 10 only for obsessions or compulsions. Being in The age range of 18-50 IQ level more than 80 based on Wechsler Adult Intelligence Scale Signing written informed consent 18 years 50 years Both Subjects with major depressive disorder, bipolar disorder, personality disorder, and schizophrenia in a way that questions the diagnose of obsessive-compulsive disorder. Pregnancy, lactation or the imminent possibility of either of these cases or use of birth control methods for female subjects (these items will be assessed by the validated urine tests) Past or current drug/alcohol abuse or dependence (these items will be assessed by the urine toxicology tests) Previous exposure to any kind of psychotropic medication (benzodiazepines, antipsychotics, antidepressants, stimulants, mood stabilizers) Previous exposure to at least 8 sessions of structured psycho-therapeutic courses Past history or current existence of neurological diseases (seizures, epilepsy syndromes, history of trauma, stroke, loss of consciousness) and other severe internal and surgical disorders Presence of any contraindication to MRI scanning, including metal implants or claustrophobia. Metal implants, pacemaker, other metal (e.g. shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MR scan, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by the neuroradiologists:"Guide to MR procedures and metallic objects", F. G. Increase in liver enzymes SGOT and SGPT more than threefold compared with baseline levels. F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Intervention group: This group, which includes subjects with a diagnosis of obsessive-compulsive disorder, will receive memantine hydrochloride (C12H21N•HCl) 10 mg twice daily in two 8-week phases (total sixteen weeks). Memantine, a non-competitive glutamate receptor antagonist, is used to treat moderate to severe Alzheimer's disease. Memantine blocks the effects of sustained and elevated levels of glutamate, which can impair neuronal function. In addition, memantine provides the conditions for increased expression of the N-methyl-diaspartate receptor gene, which causes glutamate to act at higher concentrations and actually increase the threshold. Memantine has also shown a negligible affinity for gamma-aminobutyric acid, benzodiazepine, dopamine, adrenergic, histamine, glycine and voltage-dependent receptors for calcium, sodium, or potassium. Memantine is well absorbed from the gastrointestinal tract and is linear in its therapeutic dose range. It is essentially excreted by the kidneys and unchanged in urine and has a terminal half-life of about 60 to 80 hours. Control group: This group, which includes subjects with a diagnosis of obsessive-compulsive disorder, will receive placebo of memantine twice daily for two 8-week stages (total sixteen weeks). Symptom (Obsession and Compulsions) Severity Based on Yale Brown Obsessive Compulsive Disorder Scale. Timepoint: Assessment of Severity and pattern of symptoms : at the beginning of study and before the beginning of intervention, 2 weeks after the beginning of intervention, 4 weeks after the beginning of intervention, 6 weeks after the beginning of intervention, 8 weeks after the beginning of intervention,10 weeks after the beginning of intervention, 12 weeks after the beginning of intervention. Method of measurement: Validated Yale Brown Obsessive Compulsive Disorder Scale. Neuro-Cognitive Functions. Timepoint: At the beginning of the study and then after 6th week and 12th week. Method of measurement: The Cambridge Neuropsychological Test Automated Battery (CANTAB). Functional organization of Large-Scale Brain Networks. Timepoint: At the Beginning of Study and then after 6th week and 12th week. Method of measurement: Functional Magnetic Resonance Imaging. Tehran University of Medical Sciences Approved 2020-07-22 Ethic Committee of Tehran University of Medical Sciencesl Sciences 6th floor of the Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)