]>
IRCT20130518013359N5 IRCT 2021-12-18 Mashhad University of Medical Sciences The effect of Memantine on the severity of symptoms and brain function in patients with Obsessive-Compulsive Disorder (OCD) : An Event Related Potential (ERP) study The effect of Memantine on the severity of symptoms and brain function in patients with Obsessive-Compulsive Disorder (OCD) : An Event Related Potential (ERP) study 2022-01-21 anticipated 50 Complete https://irct.ir/trial/60358 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is done using the site https://www.sealedenvelope.com. Each block has 8 members and for example can be as follows: [AABBCCDD], [ABCDABCD], [AABBDCD],… Codes A, B, C, D are assigned randomly to the intervention groups and the control group. The aforementioned site randomly selects 9 blocks from all eight-member blocks so that 50 patients can be included in the study.The allocation concealment method is by use of opaque sealed envelopes with random sequences obtained from the random allocation step, Blinding description: As our data are collected step by step and patients are gradually included in the study, concerning the time of inclusion and at the beginning of inclusion according to the sequence obtained in the randomization stage, the patients will be assigned to either control groups or interventions groups. These codes are provided to the researcher present in the physician's office. It is worth mentioning that this researcher should be fully aware of the type of code. The researcher is also provided with the medications in terms of the assigned number (D or C or B or A) and is fully aware of the fact that which medication is Memantine or placebo, as well. (This researcher is engaged neither in prescribing and evaluating the treatments, nor in analyzing data, and is exclusively responsible for maintaining codes and delivering medications to the patients based on a random code allocated by the physician.) The assigned code is recorded in the CRF form. Initially, the prepared codes are given to the researcher, if the inclusion criteria are fulfilled and based on the codes, the patient is randomly included in one group. The allocated code is documented in the CRF form and the researcher takes the drugs or placebo into account based on the code assigned to the patient. After taking either the medication or placebo for three months by the patients, in the clinic of Ebn-e-Sina Hospital, the patients are appraised by a physician who has no idea which drug the patients have received and is only aware of the assigned codes and then carries out the appropriate evaluations. After documentation, the results in the form of codes are provided to the person who performs the data analysis. The data analysis is performed while the data analyzer has no information about the type of the taken medication, and all confidential information is recorded and stored without mentioning the patient's name. 3 obsessive-compulsive disorder. Intervention 1: Intervention group: Patients are selected from outpatients who visit the clinic of EbneSina Hospital. In the intervention group, patients diagnosed with obsessive-compulsive disorder, who meet the inclusion and exclusion criteria, will randomly add one of the following four interventions to their high-dose (SSRI) regimen. (This study will be performed on patients with obsessive-compulsive disorder who have been on high doses of SSRI for at least 8 weeks but have a Y-BOCS index score higher than 15) The severity of symptoms of obsessive-compulsive disorder will be assessed using the Yale Brown Obsessive-Compulsive Disorder Scale before intervention and 1 month, 2 months and 3 months after intervention. Quantitative electroencephalography (QEEG) will be done before the intervention and 3 months after the intervention. Intervention group1: high dose of SSRI (High doses of SSRIs include sertraline: maximum 200mg / day, paroxetine: maximum 60mg / day, fluoxetine: maximum 80mg / day, fluvoxamine: maximum 300mg / day) + memantine (20 mg/day). The main medication, Memantine, is purchased from Sobhan pharmaceutical company. Intervention 2: Control group: high dose of SSRI + placebo The placebo tablet contains all the ingredients of the main pill and only lacks the active ingredient Memantine, and will receive 4 tablets a day for 3 months in addition to the standard treatment regimen for obsessive-compulsive patients. The placebo tablet, which is similar to the main medication in terms of shape and color is made in Mashhad School of Pharmacy in accordance with the principles of GLP. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting 6 months after publication To whom: only available for people working in academic institutions Conditions: only available for people working in academic institutions and there is not another condition Where to obtain: sadjadia@mums.ac.ir How to obtain: sadjadia@mums.ac.ir Comments:
public Sadjadi alireza
BuAli square, Horr Ameli Boulevard, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 83134- 91959 +98 51 3711 2701 sadjadia@mums.ac.ir Mashhad University of Medical Sciences scientific Sadjadi Alireza
مشهد، میدان بوعلی، بلوار حر عاملی
Mashhad Iran (Islamic Republic of) 83134- 91959 +98 51 3711 2701 sadjadia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with obsessive-compulsive disorder who have been treated with high doses of SSRI for at least 8 weeks but whose Y-BOCS index is higher than cut-off 15. People aged 18 to 60 years Obtain patient informed consent 18 years 60 years Both Pregnancy or breastfeeding Using serotonergic drugs other than SSRIs Use of NMDA receptor antagonists other than memantine Psychotic and bipolar disorders (based on DSM-5 criteria) Major Depressive Disorder (Based on DSM-IV-TR Criteria) Other anxiety disorders (such as panic disorder, post-traumatic stress disorder (PTSD), general anxiety disorder (GAD) Abuse or dependence on drugs or alcohol Liver dysfunction (LFT> 3ULN) Kidney dysfunction (GFR <60 ml / kg / min) Thyroid Disorders (Based on Thyroid Function Test) History of seizures Cognitive-behavioral therapy F42 Obsessive-compulsive disorder Treatment - Drugs Treatment - Drugs Intervention group: Patients are selected from outpatients who visit the clinic of EbneSina Hospital. In the intervention group, patients diagnosed with obsessive-compulsive disorder, who meet the inclusion and exclusion criteria, will randomly add one of the following four interventions to their high-dose (SSRI) regimen. (This study will be performed on patients with obsessive-compulsive disorder who have been on high doses of SSRI for at least 8 weeks but have a Y-BOCS index score higher than 15) The severity of symptoms of obsessive-compulsive disorder will be assessed using the Yale Brown Obsessive-Compulsive Disorder Scale before intervention and 1 month, 2 months and 3 months after intervention. Quantitative electroencephalography (QEEG) will be done before the intervention and 3 months after the intervention. Intervention group1: high dose of SSRI (High doses of SSRIs include sertraline: maximum 200mg / day, paroxetine: maximum 60mg / day, fluoxetine: maximum 80mg / day, fluvoxamine: maximum 300mg / day) + memantine (20 mg/day). The main medication, Memantine, is purchased from Sobhan pharmaceutical company. Control group: high dose of SSRI + placebo The placebo tablet contains all the ingredients of the main pill and only lacks the active ingredient Memantine, and will receive 4 tablets a day for 3 months in addition to the standard treatment regimen for obsessive-compulsive patients. The placebo tablet, which is similar to the main medication in terms of shape and color is made in Mashhad School of Pharmacy in accordance with the principles of GLP. Evaluation of the effect of memantine in comparison with placebo on reducing the severity of symptoms in patients with obsessive-compulsive disorder based on (Y-BOCS) YALE-BROWN OBSESSIVE COMPULSIVE SCALE. Timepoint: Before intervention and 1 month, 2 months and 3 months after intervention. Method of measurement: Yale–Brown Obsessive Compulsive Scale. Comparison of quantitative electroencephalographic (QEEG) changes in different groups. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Quantitative Electroencephalogram. Mashhad University of Medical Sciences Approved 2021-10-12 Mashhad University of Medical Sciences Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)