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IRCT20140120016280N5 IRCT 2021-05-18 Tehran University of Medical Sciences Evaluation of Ketamine Hydrochloride's Effect in Obsessive-Compulsive Disorde Evaluation of Ketamine Hydrochloride’s Effect on Symptom Characteristics and Neuronal Networks Organization in Patients with Obsessive Compulsive Disorder: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial 2021-07-23 anticipated 60 Complete https://irct.ir/trial/48762 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 15. Regarding determined sample size 60, 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 formation and placebo effects are considerable, the subjects and the main investigator that is assessor and also the author of the manuscript would be held blinded. such a way that, the primary neuro-psychological assessments will be executed by the trained clinical psychologist. Staff responsible for preparation of trial medications and randomization process were not further involved in the study. Ketamine / placebo injections are also given by an anesthesiologist who is unaware of the type of allocation (medication / placebo). The patient will also be informed during the registration process that he or she is receiving medication or placebo, and if he or she consents and participates in the plan, will be kept blind to the type of allocation at the time of the ketamine / placebo injection. 3 Obsessive Compulsive Disorder. Intervention 1: Intervention group: This group, which includes subjects diagnosed with obsessive-compulsive disorder, receives injectable ketamine hydrochloride as an intravenous infusion at a dose of 0.5 mg per kg. Ketamine, a non-competitive glutamate receptor antagonist, has recently been approved for anesthesia and used to treat major depressive disorder. Ketamine blocks the effects of persistent, elevated levels of glutamate, which can cause neuronal dysfunction. In addition, memantine provides the conditions for increased expression of the N-methyl di-aspartate receptor gene, which causes glutamate to act at higher concentrations and, in fact, increases the threshold. Ketamine has also been shown to be receptive to gamma-aminobutyric acid, benzodiazepine, dopamine, adrenergic, histamine, glycine, and voltage-gated calcium, sodium, or potassium channels. Intervention 2: Control group: This group, which includes subjects with a diagnosis of obsessive-compulsive disorder, will receive placebo of Ketamine (normal saline), based on the standard protocol for ketamine injection. Yes - There is a plan to make this available What will be shared: Information of the main (primary outcome) and the secondary outcomes like 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 Dr. 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) 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 25 for obsessions and compulsions Lack of sufficient response to one period of standard treatment with enough dose and duration (less than 25 percent reduction in symptom severity) Being in the age range of 18-40 IQ level more than 80 Signing written informed consent 18 years 40 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 substance/alcohol abuse or dependence 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. F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Intervention group: This group, which includes subjects diagnosed with obsessive-compulsive disorder, receives injectable ketamine hydrochloride as an intravenous infusion at a dose of 0.5 mg per kg. Ketamine, a non-competitive glutamate receptor antagonist, has recently been approved for anesthesia and used to treat major depressive disorder. Ketamine blocks the effects of persistent, elevated levels of glutamate, which can cause neuronal dysfunction. In addition, memantine provides the conditions for increased expression of the N-methyl di-aspartate receptor gene, which causes glutamate to act at higher concentrations and, in fact, increases the threshold. Ketamine has also been shown to be receptive to gamma-aminobutyric acid, benzodiazepine, dopamine, adrenergic, histamine, glycine, and voltage-gated calcium, sodium, or potassium channels. Control group: This group, which includes subjects with a diagnosis of obsessive-compulsive disorder, will receive placebo of Ketamine (normal saline), based on the standard protocol for ketamine injection. 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, 3 days after intervention and then 10 days after intervention. Method of measurement: Validated Yale Brown Obsessive Compulsive Disorder Scale. Functional organization of Large-Scale Brain Networks. Timepoint: 72 hours before intervention, and then 72 hours after intervention and 10 days after intervention. Method of measurement: Functional Magnetic Resonance Imaging. Tehran University of Medical Sciences Approved 2021-04-21 Ethic Committee of Tehran University of Medical 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)