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
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Protocol summary
Two intervention groups: add-on Memantine and add-on Placebo
Intervention group: Memantine. Control group: Placebo
Two intervention groupsIntervention group: add-on Memantine and add-on. Control group: Placebo
1) Symptom (Obsession and Compulsions) Severity Based on Yale Brown Obsessive Compulsive Disorder Scale.
2) Response rate to Memantine treatment based on Yale Brown Obsessive Compulsive Disorder Scale
Symptoms (Obsession and Compulsions) severity; Response rate to Memantine treatment.
1) SymptomSymptoms (Obsession and Compulsions) Severity Based on Yale Brown Obsessive Compulsive Disorder Scale. 2)severity; Response rate to Memantine treatment based on Yale Brown Obsessive Compulsive Disorder Scale.
General information
The reason for the updating is to make changes to the design of the clinical trial; In the previous mode, the parallel design was considered, and in the current edited mode, the parallel design is considered.
Since the start of the project, a small number of study subjects have reached the middle weeks of assessment / intervention, and data analysis from neuroimaging (secondary outcome variable) and cognitive assessment (secondary outcome variable) have also begun. The results have indicated that the evaluation of the neurocognitive response / non-response pattern to treatment in sequential parallel design with current number and form of participation during the existing pandemic condition (this study is for people with obsessive-compulsive disorder) is very complex and valid interpretation is hard to provide; Switching to parallel design can solve this problem.
In addition, after a statistical review, it was found that due to the greater probability of attrition and excluding from the project by the study subjects in Covid conditions, the implementation of sequential parallel design with respect to the primary and secondary outcome variables, will face with many difficulties.
In this edited version, the sections related to the intervention groups have been changed. The other components and dimensions of the project, including all pre-/post study evaluations, the considerations of the execution of the work and the frequency and form of sampling are as stated in the approved draft.
The reason for the updating is to make changes to the assessment timing of the clinical trial outcomes; such that, in the previous mode, 16 weeks was considered, but in the current edited mode, it changed to 12 weeks. Respectfully, the reason for this change request is explained below.
Since the start of the project, a small number of study subjects have reached the middle weeks of assessment / intervention, and data analysis from neuroimaging (secondary outcome variable) and cognitive assessment (secondary outcome variable) have also begun. The results have indicated that the evaluation of the neurocognitive response / non-response pattern to treatment 16-weeks design with current number and form of participation during the existing pandemic condition (this study is for people with obsessive-compulsive disorder) is very complex and valid interpretation is hard to provide; Switching to 12 weeks time frame can solve this problem.
In this edited version, the entire timing frame of primary outcome variable (assessment of symptom severity of obsessive compulsive disorder using Yale-Brown Scale) changed from 16 weeks to 12 weeks with the same assessment frequency of two-weeks. Additionally, the timing of assessment of secondary outcome variable of neurocognitive function and also functional organization of large-scale brain networks changed from 16 weeks to 12 weeks; both of these with 6-weeks intervals.
The reason for the updating is to make changes to the designassessment timing of the clinical trial outcomes; Insuch that, in the previous mode, the parallel design16 weeks was considered, andbut in the current edited mode, it changed to 12 weeks. Respectfully, the parallel designreason for this change request is consideredexplained below. Since the start of the project, a small number of study subjects have reached the middle weeks of assessment / intervention, and data analysis from neuroimaging (secondary outcome variable) and cognitive assessment (secondary outcome variable) have also begun. The results have indicated that the evaluation of the neurocognitive response / non-response pattern to treatment in sequential parallel16-weeks design with current number and form of participation during the existing pandemic condition (this study is for people with obsessive-compulsive disorder) is very complex and valid interpretation is hard to provide; Switching to parallel design12 weeks time frame can solve this problem. In addition, after a statistical review, it was found that due to the greater probability of attrition and excluding from the project by the study subjects in Covid conditions, the implementation of sequential parallel design with respect to the primary and secondary outcome variables, will face with many difficulties. In this edited version, the sections relatedentire timing frame of primary outcome variable (assessment of symptom severity of obsessive compulsive disorder using Yale-Brown Scale) changed from 16 weeks to 12 weeks with the intervention groups have been changed. The other components and dimensionssame assessment frequency of the project, including all pretwo-/post study evaluationsweeks. Additionally, the considerationstiming of the executionassessment of the worksecondary outcome variable of neurocognitive function and the frequency and formalso functional organization of sampling are as stated in the approved draftlarge-scale brain networks changed from 16 weeks to 12 weeks; both of these with 6-weeks intervals.
دلیل بروزرسانی، اعمال تغییرات در طراحی کارآزمایی بالینی است؛ به نحوی که در حالت قبلی، طراحی موازی متوالی در نظر گرفته شده بود و در حالت ویرایش شده فعلی، طراحی موازی مدنظر است.
از زمان شروع طرح، تعداد اندکی از آزمودنیهای مطالعه به هفتههای میانی ارزیابی/مداخله رسیدهاند و آنالیز دادههای بدست آمده از تصویربرداری عصبی (متغیر پیامد ثانویه) و ارزیابی شناختی (متغیر پیامد ثانویه) نیز آغاز شده است. نتایج بیانگر این موضوع بوده اند که ارزیابی الگوی عصب-شناختی پاسخ/عدم پاسخ به درمان در طراحی موازی متوالی با این میزان و شکل از مشارکت حین شرایط پاندمی موجود ( این تحقیق در مورد افراد مبتلا به اختلال وسواس فکری-عملی است)، بسیار پیچیده است و قابلیت تفسیر معتبر را ندارد؛ تغییر به سمت طراحی موازی میتواند سبب رفع این مشکل گردد.
علاوه بر این، پس از یک بررسی آماری مجدد، مشخص گردید که با توجه احتمال بیشتر ریزش و خارج شدن از طرح از سوی آزمودنیهای مطالعه در شرایط کووید، اجرای طراحی موازی متوالی با توجه به متغیرهای پیامد اولیه و ثانویه در نظر گرفته شده، با دشواریهای بسیاری مواجه خواهد بود.
در این نسخه ویرایش شده، بخش مربوط به گروه های مداخله تغییر داده شده است. اجزا وابعاد دیگر طرح از جمله تمام بررسیهای پیش و پس از ورود به مطالعه، ملاحظات اجرای کار و فرکانس و شکل نمونهگیری به همان صورتی است که در پیشنویس تأیید شده آمده است.
دلیل بروزرسانی، اعمال تغییرات در زمانبندی ارزیابی پیامدهای کارآزمایی بالینی است؛ به نحوی که در حالت قبلی، شانزده هفته در نظر گرفته شده بود، اما در نسخه ویرایش شده ی حاضر، به 12 هفته تغییر پیدا کرد. احترما، دلیل این درخواست تغییر ، در ادامه توضیح داده شده است.
از زمان شروع طرح، تعداد اندکی از آزمودنیهای مطالعه به هفتههای میانی ارزیابی/مداخله رسیدهاند و آنالیز دادههای بدست آمده از تصویربرداری عصبی (متغیر پیامد ثانویه) و ارزیابی شناختی (متغیر پیامد ثانویه) نیز آغاز شده است. نتایج بیانگر این موضوع بوده اند که ارزیابی الگوی عصب-شناختی پاسخ/عدم پاسخ به درمان در طراحی شانزده هفته ای با این میزان و شکل از مشارکت حین شرایط پاندمی موجود ( این تحقیق در مورد افراد مبتلا به اختلال وسواس فکری-عملی است)، بسیار پیچیده است و قابلیت تفسیر معتبر را ندارد؛ تغییر به سمت زمانبندی 12 هفته ای میتواند سبب رفع این مشکل گردد.
در این نسخه ویرایش شده، زمانبندی کلی ارزیابی متغیر پیامد اولیه (ارزیابی شدت علائم اختلال وسواس فکری-عملی با استفاده از ابزار ییل-بران) از شانزده هفته به دوازده هفته با همان نرخ ارزیابی دو هفته یک بار، تغییر پیدا کرد. علاوه بر این، زمانبندی ارزیابی متغیر پیامد ثانویه ی کارکردهای عصب-شناختی و نیز متغیر سازمانبندی کارکردی شبکه های عصبی مقیاس بزرگ مغز، از شانزده هفته به دوازده هفته تغییر پیدا کرد. هر دو با فواصل 6 هفته ای.
دلیل بروزرسانی، اعمال تغییرات در طراحیزمانبندی ارزیابی پیامدهای کارآزمایی بالینی است؛ به نحوی که در حالت قبلی، طراحی موازی متوالیشانزده هفته در نظر گرفته شده بود و، اما در حالتنسخه ویرایش شده فعلیی حاضر، طراحی موازی مدنظربه 12 هفته تغییر پیدا کرد. احترما، دلیل این درخواست تغییر ، در ادامه توضیح داده شده است. از زمان شروع طرح، تعداد اندکی از آزمودنیهای مطالعه به هفتههای میانی ارزیابی/مداخله رسیدهاند و آنالیز دادههای بدست آمده از تصویربرداری عصبی (متغیر پیامد ثانویه) و ارزیابی شناختی (متغیر پیامد ثانویه) نیز آغاز شده است. نتایج بیانگر این موضوع بوده اند که ارزیابی الگوی عصب-شناختی پاسخ/عدم پاسخ به درمان در طراحی موازی متوالیشانزده هفته ای با این میزان و شکل از مشارکت حین شرایط پاندمی موجود ( این تحقیق در مورد افراد مبتلا به اختلال وسواس فکری-عملی است)، بسیار پیچیده است و قابلیت تفسیر معتبر را ندارد؛ تغییر به سمت طراحی موازیزمانبندی 12 هفته ای میتواند سبب رفع این مشکل گردد. علاوه بر این، پس از یک بررسی آماری مجدد، مشخص گردید که با توجه احتمال بیشتر ریزش و خارج شدن از طرح از سوی آزمودنیهای مطالعه در شرایط کووید، اجرای طراحی موازی متوالی با توجه به متغیرهای پیامد اولیه و ثانویه در نظر گرفته شده، با دشواریهای بسیاری مواجه خواهد بود. در این نسخه ویرایش شده، بخش مربوطزمانبندی کلی ارزیابی متغیر پیامد اولیه (ارزیابی شدت علائم اختلال وسواس فکری-عملی با استفاده از ابزار ییل-بران) از شانزده هفته به گروهدوازده هفته با همان نرخ ارزیابی دو هفته یک بار، تغییر پیدا کرد. علاوه بر این، زمانبندی ارزیابی متغیر پیامد ثانویه ی کارکردهای عصب-شناختی و نیز متغیر سازمانبندی کارکردی شبکه های مداخلهعصبی مقیاس بزرگ مغز، از شانزده هفته به دوازده هفته تغییر داده شده استپیدا کرد. اجزا وابعاد دیگر طرح از جمله تمام بررسیهای پیش و پس از ورود به مطالعه، ملاحظات اجرای کار و فرکانس و شکل نمونهگیری به همان صورتی است که در پیشنویس تأیید شده آمده استهر دو با فواصل 6 هفته ای.
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.
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.
Since the current study will be performed within the neuropsychiatry context and the probability of bias formation and placebo effects are considerable,theconsiderable, the subjects and the main investigator that is assessor and also, the author of the manuscriptassessor, would be held blinded. such a way thatTherefore, the primary neuro-psychologicalgeneral evaluations, neuropsychological assessments, and patient preparation for neuroimaging will be executed by thea trained clinical psychologist, based on a table that every subject has a distinct code. Staff responsible for preparation ofpreparing trial medications and the randomization process werewill not be further involved in the study.
به دلیل اینکه مطالعه ی حاضر در فضای عصب-روانپزشکی به اجرا در خواهد آمد، و احتمال پیدایش سوگیری و نیز اثرات دارونما قابل توجه است، آزمودنی ها و نیز محقق اصلی که ارزیابی کننده و نویسنده ی پیش نویس مقاله است، کور نگه داشته خواهد شد. به گونه ای که ارزیابی های اولیه روانشناختی بیمار توسط روانشناس بالینی آموزش دیده اجرا خواهد شد.
به دلیل اینکه مطالعه ی حاضر در بستر عصب-روانپزشکی به اجرا در خواهد آمد، و احتمال پیدایش سوگیری و نیز اثرات دارونما قابل توجه است، آزمودنی ها و نیز محقق اصلی که ارزیابی کننده و نیز نویسنده ی پیش نویس مقاله است، کور نگه داشته خواهد شد. بنابراین، بررسی های های کلی اولیه، ارزیابی های روانشناختی و آماده سازی بیمار برای تصویربرداری عصبی بیمار توسط ِیک روانشناس بالینی آموزش دیده، طبق یک جدول که هر آزمودنی یک کد مجزا دارد، اجرا خواهد شد.
افرادی که مسئول آماده سازی داروهای کارآزمایی و روند تصادفی سازی هستند، بیش از این درگیر مطالعه نخواهند شد.
به دلیل اینکه مطالعه ی حاضر در فضایبستر عصب-روانپزشکی به اجرا در خواهد آمد، و احتمال پیدایش سوگیری و نیز اثرات دارونما قابل توجه است، آزمودنی ها و نیز محقق اصلی که ارزیابی کننده و نیز نویسنده ی پیش نویس مقاله است، کور نگه داشته خواهد شد. به گونه ای کهبنابراین، بررسی های های کلی اولیه، ارزیابی های اولیه روانشناختی و آماده سازی بیمار برای تصویربرداری عصبی بیمار توسط ِیک روانشناس بالینی آموزش دیده، طبق یک جدول که هر آزمودنی یک کد مجزا دارد، اجرا خواهد شد. افرادی که مسئول آماده سازی داروهای کارآزمایی و روند تصادفی سازی هستند، بیش از این درگیر مطالعه نخواهند شد.
Primary outcomes
#1
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, 14 weeks after the beginning of intervention, 16 weeks after the beginning of intervention.
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.
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, 14 weeks after the beginning of intervention, 16 weeks after the beginning of intervention.
اندازه گیری شدت و شکل علائم در ابتدای مطالعه ( قبل از شروع مداخله)، 2 هفته پس از شروع مداخله، 4 هفته پس از شروع مداخله، 6 هفته پس از شروع مداخله، 8 هفته پس از شروع مداخله، 10 هفته پس از شروع مداخله، 12هفته پس از شروع مداخله، 14 هفته هفته پس از شروع مداخله، 16 هفته پس از شروع مداخله
اندازه گیری شدت و شکل علائم در ابتدای مطالعه ( قبل از شروع مداخله)، 2 هفته پس از شروع مداخله، 4 هفته پس از شروع مداخله، 6 هفته پس از شروع مداخله، 8 هفته پس از شروع مداخله، 10 هفته پس از شروع مداخله، 12هفته پس از شروع مداخله.
اندازه گیری شدت و شکل علائم در ابتدای مطالعه ( قبل از شروع مداخله)، 2 هفته پس از شروع مداخله، 4 هفته پس از شروع مداخله، 6 هفته پس از شروع مداخله، 8 هفته پس از شروع مداخله، 10 هفته پس از شروع مداخله، 12هفته پس از شروع مداخله، 14 هفته هفته پس از شروع مداخله، 16 هفته پس از شروع مداخله.
Secondary outcomes
#1
At the beginning of the study and then after 8th week and 16th week
At the beginning of the study and then after 6th week and 12th week
At the beginning of the study and then after 8th6th week and 16th12th week
ابتدای مطالعه و سپس در انتهای هفته ی هشتم و شانزدهم
ابتدای مطالعه و سپس در انتهای هفته ی ششم و دوازدهم
ابتدای مطالعه و سپس در انتهای هفته ی هشتمششم و شانزدهمدوازدهم
#2
At the Beginning of Study and then after 8th week and 16th week
At the Beginning of Study and then after 6th week and 12th week
At the Beginning of Study and then after 8th6th week and 16th12th week
ابتدای مطالعه و سپس در انتهای هفته ی هشتم و شانزدهم
ابتدای مطالعه و سپس در انتهای هفته ی ششم و دوازدهم
ابتدای مطالعه و سپس در انتهای هفته ی هشتمششم و شانزدهمدوازدهم
Protocol summary
Study aim
Evaluation of Memantine’s Effect on Symptom Characteristics, Neuro-Cognitive Functioning and Neuronal Networks Organization in Patients with Obsessive-Compulsive Disorder
This study will be conducted in a randomized double-blind clinical trial setting at Jami Neuropsychiatry Clinic and National Brain Mapping Laboratory, within the determined temporal duration.
Participants/Inclusion and exclusion criteria
Patients with Obsessive-Compulsive Disorder/
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, within the age range of 18-50 years old will be included.
Subjects with major depressive disorder, bipolar disorder, personality disorder, and schizophrenia in a way that questions the diagnose of obsessive-compulsive disorder, past or current drug/alcohol abuse or dependence,
previous exposure to any kind of psychotropic medication (benzodiazepines, antipsychotics, antidepressants, stimulants, mood stabilizers), past or current neurological disorders (Seizures, Epileptic Syndromes, Head Trauma, Stroke, Loss of consciousness), and other severe internal and surgical disorders will not be included.
Intervention groups
Intervention group: Memantine. Control group: Placebo
Main outcome variables
Symptoms (Obsession and Compulsions) severity; Response rate to Memantine treatment.
General information
Reason for update
The reason for the updating is to make changes to the assessment timing of the clinical trial outcomes; such that, in the previous mode, 16 weeks was considered, but in the current edited mode, it changed to 12 weeks. Respectfully, the reason for this change request is explained below.
Since the start of the project, a small number of study subjects have reached the middle weeks of assessment / intervention, and data analysis from neuroimaging (secondary outcome variable) and cognitive assessment (secondary outcome variable) have also begun. The results have indicated that the evaluation of the neurocognitive response / non-response pattern to treatment 16-weeks design with current number and form of participation during the existing pandemic condition (this study is for people with obsessive-compulsive disorder) is very complex and valid interpretation is hard to provide; Switching to 12 weeks time frame can solve this problem.
In this edited version, the entire timing frame of primary outcome variable (assessment of symptom severity of obsessive compulsive disorder using Yale-Brown Scale) changed from 16 weeks to 12 weeks with the same assessment frequency of two-weeks. Additionally, the timing of assessment of secondary outcome variable of neurocognitive function and also functional organization of large-scale brain networks changed from 16 weeks to 12 weeks; both of these with 6-weeks intervals.
Acronym
IRCT registration information
IRCT registration number:IRCT20140120016280N4
Registration date:2020-07-30, 1399/05/09
Registration timing:prospective
Last update:2021-08-01, 1400/05/10
Update count:3
Registration date
2020-07-30, 1399/05/09
Registrant information
Name
Mahmoudreza Hadjighassem
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 218899111823
Email address
mhadjighassem@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of Memantine’s Effect on Symptom Characteristics in Patients with Obsessive Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciencesl Sciences
Street address
6th floor of the Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.269
Health conditions studied
1
Description of health condition studied
Obsessive Compulsive Disorder (OCD)
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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)
2
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Jami Neuropsychiatry Clinic
Full name of responsible person
Mohammad Arbabi
Street address
Darabnia Alley, Mina Square, Mirdamad Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 2292 6519
Fax
Email
marbabid@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Sixth Floor, Central Organization of Tehran University of Medical Science, Qods Street
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8889 3978
Email
tums_edu@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Hadjighassem
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 02143052000 , +98 02188991102
Fax
+98 21 8899 1117
Email
mhadjighassem@tums.ac.ir
Web page address
http://satim.tums.ac.ir/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Hadjighassem
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 02143052000 , +98 02188991102
Fax
+98 21 8899 1117
Email
mhadjighassem@tums.ac.ir
Web page address
http://satim.tums.ac.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lida Shafaghi
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 02143052000 , +98 02188991102
Email
lshafaghi@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information of the main (primary outcome) and the secondary outcomes like neurocognitive functioning and neuronal networks reorganization outcome could be shared.
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
Research data will be available for the researchers of universities and scientific institutes and also relevant investigators of the industries.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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.