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IRCT20140120016280N3 IRCT 2019-08-11 Tehran University of Medical Sciences Evaluation of Bumetanide’s Effect on Symptom Characteristics in Patients with Obsessive Compulsive Disorder Evaluation of Bumetanide’s Effect on Symptom Characteristics ( Based on YBOCS) in Patients with Resistant Obsessive Compulsive Disorder Comparing to Selective Serotonin Reuptake Inhibitors 2019-08-23 anticipated 31 Complete https://irct.ir/trial/37141 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not 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 70, Quadratic blocks will be produced using the online website: www.sealedenvelope.com, 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 main investigator that is assessor and also the author of the manuscript would be held blinded. such a way that, the primary neuropsychological assessments will be executed by the trained clinical psychologist. 2-3 Obsessive Compulsive Disorder (OCD). Intervention 1: Resistant Patient Group that receive Bumetanide in addition to the background Serotonin Reuptake Inhibitors (SRIs). Bumetanide, 3-butylamino-4-phenoxy-5-sulfamoylbenzoic acid, which is a chemical compound that inhibits Na-K-Cl-Co transporter, will be added to the background medications in two phases including: titration, steady state and then will be tapered down. This Therapeutic protocol will be started by 1 milligram daily oral dose and then will be increased to 2 milligrams daily based on patient response and adverse effects profile. Intervention 2: Resistant Patient Group that Receive the standard treatment (Antipsychotics) in addition to the background Serotonin Reuptake Inhibitors (SRIs). Generally, the next standard treatment line in these patients is using low-dose second generation antipsychotics. The most common prescribed ones are risperidon and olanzapine. Yes - There is a plan to make this available What will be shared: Information of the main (primary outcome) and the secondary outcomes like gene expression changes and neuronal networks reorganization outcome can 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 (Dean 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) 1. Confirmed Diagnosis of Resistant OCD Age range of 18-50 years IQ level more than 80 based on Wechsler Adult Intelligence Scale 18 years 50 years Both Comorbidities like MDD, Bipolar Disorder, Personality Disorder, Schizophrenia Drug Adverse Effects Pregnancy, Breast Feeding (Based on self report data and urinary detection) Drug and alcohol use and dependance (Based on self report data and urinary detection) Benzodiazepine use within 3 preceding months Furesemide and other diuretic and cardiovascular drugs use Sulfur and its derivatives sensitivity Neurological Disorders(seizure, trauma, ischemic stroke, surgery) Presence of MRI SCanning absolute and partial contraindications F42 Obsessive-compulsive disorder Treatment - Drugs Treatment - Drugs Resistant Patient Group that receive Bumetanide in addition to the background Serotonin Reuptake Inhibitors (SRIs). Bumetanide, 3-butylamino-4-phenoxy-5-sulfamoylbenzoic acid, which is a chemical compound that inhibits Na-K-Cl-Co transporter, will be added to the background medications in two phases including: titration, steady state and then will be tapered down. This Therapeutic protocol will be started by 1 milligram daily oral dose and then will be increased to 2 milligrams daily based on patient response and adverse effects profile Resistant Patient Group that Receive the standard treatment (Antipsychotics) in addition to the background Serotonin Reuptake Inhibitors (SRIs). Generally, the next standard treatment line in these patients is using low-dose second generation antipsychotics. The most common prescribed ones are risperidon and olanzapine. Symptom (Obsession and Compulsions) Severity Based on Yale Brown Obsessive Compulsive Disorder Scale. Timepoint: Assessment of Severity and pattern of symptoms : 1. In the beginning of Study and before intervention, 2. 10 days after intervention, 3. 20 days after intervention, 4. 30 days after intervention, 5. 40 days after intervention, 6. 50 days after intervention, 7. 60 days after intervention, 8. 70 days after intervention. Method of measurement: Validated Yale Brown Obsessive Compulsive Disorder Scale. Alteration in Neuro-Cognitive Functioning. Timepoint: In the Beginning of Study and then after Study Completion. Method of measurement: the Cambridge Neuropsychological Test Automated Battery (CANTAB). Assessment of Functional Reorganization of Large Scale Brain Networks. Timepoint: Before the beginning of the clinical trial and immediately after the end of that. Method of measurement: Functional Magnetic Resonance Imaging. Expression of Na-K-Cl Co transporter (NKCC1) in Lymphocytes of the Peripheral Blood. Timepoint: Before the Beginning of the Clinical Trial and Immediately after that. Method of measurement: Real Time Polymerase Chain Reaction (RT-PCR) and Western Analysis. Expression of K-Cl Co transporter in lymphocyte of the peripheral blood. Timepoint: Before the beginning of the Clinical Trial and Immediately after that. Method of measurement: Real Time Polymerase Chain Reaction (RT-PCR) and Western Analysis. Tehran University of Medical Sciences Approved 2018-11-27 Ethic Committee of Tehran University of Medical Sciencesl Sciences 13th floor, Block A, Ministry of Health and Medical Education, Simaye Iran Street, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)