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Evaluating effects of Rivastigmine in Electroconvulsive therapy-induced cognitive side effects in patients receiving Electroshock; A Randomized double blind placebo-controled clinical trial

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History
# Registration date Revision Id
3 2020-12-03, 1399/09/13 162641
2 2020-05-18, 1399/02/29 134952
1 2020-05-18, 1399/02/29 134880
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  • Protocol summary

    Determining the efficacy of Rivastigmine on Cognitive Examination Scores. Determining the role of age and gender, patients' underlying disease, patients' medications used and number of them, type of electroshock and number of hospitalization days in response to Rivastigmine.
    Determining the efficacy of Rivastigmine on Cognitive Examination Scores. Determining the role of age & gender, patients' underlying diseases, their medications, type, number, duration, current intensity of ECT and severity of cognitive impairment and hospitalization days in that probable effect.
    تعیین اثر بخشی یا عدم اثر بخشی ریواستیگمین و میزان آن بر نمره ارزیابی های شناختی تعیین نقش سن و جنسیت، بیماری های زمینه ای بیماران، دارو های مصرفی بیماران و تعداد آن ها، نوع انجام الکتروشوک و تعداد روز های بستری در پاسخ دهی به ریواستیگمین
    تعیین اثر بخشی یا عدم اثر بخشی ریواستیگمین و میزان آن بر نمره ارزیابی های شناختی تعیین نقش سن و جنسیت، بیماری های زمینه ای بیماران و علت دریافت الکتروشوک، دارو های مصرفی بیماران و تعداد آن ها، نوع و تعداد و مدت زمان و شدت جریان الکتروشوک و تعداد روز های بستری و شدت افت شناختی در پاسخ دهی به ریواستیگمین
    Roozbeh Hospital, Tehran University of Medical Sciences Patients treat with Rivastigmine for 3 months (1.5-3 mg twice daily). Testing 3 times (Baseline, after 1 month and 3 month). Researchers who admit patients and take tests from them and also patients are blind. The main researcher accomplish individualized block randomization and coding.
    Roozbeh Hospital, Tehran University of Medical Sciences intervention: Rivastigmine (1.5-3 mg) or placebo twice daily for 3 months Testing (Baseline, after the last ECT and 1 month then 3 months after the start of intervention) Researchers who admit patients and take tests from them and also the patients are blind. The main researcher accomplish individualized block randomization and coding.
    مطالعه در بیمارستان روزبه دانشگاه علوم پزشکی تهران بیماران دچار افت شناختی پس از آخرین مرحله دریافت الکتروشوک به مدت 3 ماه تحت درمان با ریواستیگمین قرار می گیرند. دوز ریواستگمین در دو هفته ای ابتدایی 1.5 میلی گرم دو بار در روز و سپس 3 میلی گرم دو بار در روز تا انتهای مطالعه انجام تست ها در 3 مقطع (پایه، 1ماه و 3 ماه بعد از شروع) محققینی که بیماران را پذیرش می کنند و تست ها را از بیماران می گیرند و همچنین بیماران کور می شوند. محقق اصلی با تصادفی سازی بلوکی فردی و کد گذاری مقدمات کور سازی را فراهم می کند.
    مطالعه در بیمارستان روزبه دانشگاه علوم پزشکی تهران بیماران دچار افت شناختی پس از آخرین مرحله دریافت الکتروشوک به مدت 3 ماه تحت مداخله با ریواستیگمین یا پلاسبو قرار می گیرند. دوز ریواستگمین در دو هفته ای ابتدایی 1.5 میلی گرم دو بار در روز و سپس 3 میلی گرم دو بار در روز تا 3 ماه انجام تست ها در 4 مقطع (پایه، پس از الکتروشوک آخر و 1 ماه و 3 ماه بعد از شروع مداخله) محققینی که بیماران را پذیرش می کنند و تست ها را از بیماران می گیرند و همچنین بیماران کور می شوند. محقق اصلی با تصادفی سازی بلوکی فردی و کد گذاری مقدمات کور سازی را فراهم می کند.
    Inclusion: Patients 18-70 years Patients with Biploar disorder & Schizophrenia who are candidates for Electroshock(ECT) Psychiatric diagnosis of patients based on DSM IV, SCIDP criteria Patients with refractory treatment and candidate for ECT Resistance to at least 2 antipsychotics for 6 weeks at a equivalent dose of 1000 mg chlorpromazine Patients with cognitive decline after ECT diagnosed by cognitive examinations Exclusion: Patients with heart block and arrhythmia and with a history of previous Stroke and Parkinson's disease, previous cognitive impairment or dementia and severe gastrointestinal disorders or gastrointestinal bleeding and serious medical illness present use of substances
    Inclusion: Patients 18-70 years Patients with Biploar disorder & Schizophrenia who are candidates for Electroshock(ECT) Psychiatric diagnosis of patients based on DSM IV, SCIDP criteria Patients with refractory treatment and candidate for ECT Resistance to at least 2 antipsychotics for 6 weeks at a equivalent dose of 1000 mg chlorpromazine Patients with cognitive decline after ECT diagnosed by cognitive examinations Exclusion: Patients with heart block and arrhythmia and with a history of previous Stroke and Parkinson's disease, previous cognitive impairment or dementia and severe gastrointestinal disorders or gastrointestinal bleeding and serious medical illness present use of substances
    Intervention group: 1.5mg and 3mg Rivastigmine capsules. Rivastigmine Will be given to the patients initially 1.5mg twice daily for 2 weeks and then, 3mg twice daily per Oral until the end of the 3 month intervention period Control group: receiving placebo twice daily
    Intervention: 1.5mg and 3mg Rivastigmine capsules. Rivastigmine Will be given to the patients initially 1.5mg twice daily for 2 weeks and then, 3mg twice daily per Oral to the end of the 3 months intervention period Control: placebo twice daily for 3 months
    گروه مداخله: کپسول 1.5 و 3 میلی گرمی ریواستیگمین ابتدا با دوز 1.5 میلی گرم دو بار در روز به مدت 2 هفته سپس تا تکمیل دوره 3 ماهه مداخله با دوز 3 میلی گرم دو بار در روز از طریق خوراکی به بیماران داده خواهد شد. گروه کنترل: دریافت پلاسبو دو بار در روز
    گروه مداخله: کپسول 1.5 و 3 میلی گرمی ریواستیگمین ابتدا با دوز 1.5 میلی گرم دو بار در روز به مدت 2 هفته سپس تا تکمیل دوره 3 ماهه مداخله با دوز 3 میلی گرم دو بار در روز از طریق خوراکی به بیماران داده خواهد شد. گروه کنترل: دریافت پلاسبو دو بار در روز به مدت 3 ماه
    Montreal Cognitive Assessment Alzheimer's Disease Assessment Scale Addenbrooke's Cognitive Examination Mini-Mental State Examination
    Montreal Cognitive Assessment Addenbrooke's Cognitive Examination
    نمره ارزیابی شناختی مونترال نمره مقیاس ارزیابی بیماری آلزایمر نمره معاینه شناختی ادن بروک نمره معاینه کوتاه وضعیت ذهنی
    نمره ارزیابی شناختی مونترال نمره معاینه شناختی ادن بروک

  • General information

    2020-06-19, 1399/03/30
    2020-09-20, 1399/06/30
    2021-03-19, 1399/12/29
    2021-09-21, 1400/06/30
    Patients over than 18 years and less than 70 years
    Patients with diagnosis of BMD & Schizophrenia who are candidates for ECT
    Psychiatric diagnosis of patients based on DSM IV, SCIDP criteria
    Patients with refractory treatment and candidate for ECT
    Resistance to at least 2 antipsychotics for 6 weeks at a equivalent dose of 1000 mg chlorpromazine
    Patients with cognitive decline with electroshock diagnosed by neuroscientist and under cognitive evaluation by ACE, ADAS-COG, MoCA
    Patients over than 18 years and less than 70 years
    Patients with diagnosis of BMD & Schizophrenia who are candidates for ECT
    Psychiatric diagnosis of patients based on DSM IV, SCIDP criteria
    Patients with refractory treatment and candidate for ECT
    Resistance to at least 2 antipsychotics for 6 weeks at a equivalent dose of 1000 mg chlorpromazine
    Patients with cognitive decline with electroshock diagnosed by neuroscientist and under cognitive evaluation by ACE, MoCA
    بیماران بالاتر از 18 سال و کمتر از 70 سال
    تشخیص BMD و اسکیزوفرنی که کاندید دریافت ECT باشند
    تشخیص روان پزشکی بیماران بر پایه معیار DSM IV، SCIDP
    بیماران مقاوم به درمان و کاندید دریافت ECT
    مقاومت به حداقل 2 آنتی سایکوتیک به مدت 6 هفته و دوز معادل 1000 میلی گرم کلرپرومازین
    بیماران دچار افت شناختی با الکتروشوک تشخیص داده شده توسط نوروسایکولوژیست و تحت ارزیابی شناختی با ACE، ADAS-COG، MoCA
    بیماران بالاتر از 18 سال و کمتر از 70 سال
    تشخیص BMD و اسکیزوفرنی که کاندید دریافت ECT باشند
    تشخیص روان پزشکی بیماران بر پایه معیار DSM IV، SCIDP
    بیماران مقاوم به درمان و کاندید دریافت ECT
    مقاومت به حداقل 2 آنتی سایکوتیک به مدت 6 هفته و دوز معادل 1000 میلی گرم کلرپرومازین
    بیماران دچار افت شناختی با الکتروشوک تشخیص داده شده توسط نوروسایکولوژیست و تحت ارزیابی شناختی با ACE، MoCA
    Individual Block Randomization with 2 blocks in two groups of intervention and control using random numbers in Excel software. To conceal the allocation as well as to preserve blindness, an out-of-field researcher prepares random sequences of patients and encodes each patient's medication packages prior to initiating the patient selection. The medicines and placebo tablets, which are quite similar in appearance, are poured into the same cans. All pills required for each patient during the study are packed in 3-digit coded cans. The list of patient selection based on these three-digit codes is also provided to the researcher based in the field. All clinical evaluations will also be performed by another researcher who is in the field and not involved in the allocation process.
    Individual Block Randomization with 2 blocks in two groups of intervention and control To conceal the allocation as well as to preserve blindness, an out-of-field researcher prepares random sequences of patients and encodes each patient's medication packages prior to initiating the patient selection. The medicines and placebo tablets, which are quite similar in appearance, are poured into the same cans. All pills required for each patient during the study are packed in 3-digit coded cans. The list of patient selection based on these three-digit codes is also provided to the researcher based in the field. All clinical evaluations will also be performed by another researcher who is in the field and not involved in the allocation process.
    تصادفی سازی بلوکی فردی با بلوک های 2 تایی به دو گروه مداخله و کنترل با استفاده از اعداد رندوم در نرم افزار اکسل جهت پنهان سازی تخصیص و همچنین حفظ کور سازی، یکی از پژوهشگران خارج از فیلد قبل از آغاز بیمار گیری اقدام به تهیه توالی تصادفی از بیماران و کد گذاری بسته های دارویی هر بیمار می نماید. قرصهای دارو و پلاسبو که از لحاظ ظاهری کاملا مشابه هستند در قوطی های مشابه ریخته می شوند. کلیه قرصهای مورد نیاز هر بیمار در طول مدت مطالعه در قوطی های کد گذاری شده با کد 3 رقمی بسته بندی می شود. لیست بیمارگیری نیز بر اساس این کدهای سه رقمی در اختیار پژوهشگر مستقر در فیلد گذاشته می شود. کلیه ارزیابی های بالینی نیز توسط پژوهشگر دیگری در فیلد که در روند تخصیص دخالتی ندارد، انجام خواهد شد.
    تصادفی سازی بلوکی فردی با بلوک های 2 تایی به دو گروه مداخله و کنترل جهت پنهان سازی تخصیص و همچنین حفظ کور سازی، یکی از پژوهشگران خارج از فیلد قبل از آغاز بیمار گیری اقدام به تهیه توالی تصادفی از بیماران و کد گذاری بسته های دارویی هر بیمار می نماید. قرصهای دارو و پلاسبو که از لحاظ ظاهری کاملا مشابه هستند در قوطی های مشابه ریخته می شوند. کلیه قرصهای مورد نیاز هر بیمار در طول مدت مطالعه در قوطی های کد گذاری شده با کد 3 رقمی بسته بندی می شود. لیست بیمارگیری نیز بر اساس این کدهای سه رقمی در اختیار پژوهشگر مستقر در فیلد گذاشته می شود. کلیه ارزیابی های بالینی نیز توسط پژوهشگر دیگری در فیلد که در روند تخصیص دخالتی ندارد، انجام خواهد شد.

  • Health conditions studied

    #1
    ECT, Electroconvulsive therapy, Electroshock, ECT-induced Cognitive Disorders, ECT-induced Memory Disorder, Rivastigmine, Cholinesterase Inhibitors, MoCA Test, MMSE Test, ADAS Test, ACE Test, Effect of Rivastigmine on Cognitive Impairment After ECT, Effect of cholinesterase inhibitiors on cognitive impairments after electroconvulsive therapy, effect of Rivastigmine on memory
    ECT, Electroconvulsive therapy, Electroshock, ECT-induced Cognitive Disorders, ECT-induced Memory Disorder, Rivastigmine, Cholinesterase Inhibitors, MoCA, ACE, Effect of Rivastigmine on Cognitive Impairment After ECT, Effect of cholinesterase inhibitiors on cognitive impairments after electroconvulsive therapy, effect of Rivastigmine on memory
    الکتروشوک درمانی، الکتروشوک مغزی، اختلالات شناختی پس از الکتروشوک، اختلال حافظه پس از الکتروشوک، ریواستیگمین، مهار کننده های کولین استراز، تست MoCA، تست MMSE، تست ADAS، تست ACE، اثر ریواستیگمین بر اختلالات شناختی پس از الکتروشوک، اثر مهار کننده های کولین استراز بر اختلالات شناختی پس از الکتروشوک، اثر ریواستیگمین بر حافظه
    الکتروشوک درمانی، الکتروشوک مغزی، اختلالات شناختی پس از الکتروشوک، اختلال حافظه پس از الکتروشوک، ریواستیگمین، مهار کننده های کولین استراز، تست MoCA، تست ACE، اثر ریواستیگمین بر اختلالات شناختی پس از الکتروشوک، اثر مهار کننده های کولین استراز بر اختلالات شناختی پس از الکتروشوک، اثر ریواستیگمین بر حافظه

  • Primary outcomes

    #1
    At baseline, 1 month after intervention and 3 months after intervention
    Before receiving the first ECT session, after receiving the last session and 1 month after the beginning of intervention and finally 3 months after that
    ابتدای مطالعه، 1 ماه پس از شروع مداخله و 3 ماه پس از شروع مداخله
    قبل از شروع جلسات الکتروشوک، پس از آخرین الکتروشوک، 1 ماه و سپس 3 ماه پس از شروع مداخله
    #2
    Alzheimer's Disease Assessment Scale
    Addenbrooke's Cognitive Examination Score
    نمره مقیاس ارزیابی بیماری آلزایمر
    نمره معاینه شناختی ادن بروک
    At baseline, 1 month after intervention and 3 months after intervention
    Before receiving the first ECT session, after receiving the last session and 1 month after the beginning of intervention and finally 3 months after that
    ابتدای مطالعه، 1 ماه پس از شروع مداخله و 3 ماه پس از شروع مداخله
    قبل از شروع جلسات الکتروشوک، پس از آخرین الکتروشوک، 1 ماه و سپس 3 ماه پس از شروع مداخله
    Alzheimer's Disease Assessment Scale Questionnaire
    Addenbrooke's Cognitive Examination Questionnaire
    پرسشنامه مقیاس ارزیابی بیماری آلزایمر
    پرسشنامه معاینه شناختی ادن بروک
    #3
    Addenbrooke's Cognitive Examination Score
    empty
    نمره معاینه شناختی ادن بروک
    empty
    At baseline, 1 month after intervention and 3 months after intervention
    empty
    ابتدای مطالعه، 1 ماه پس از شروع مداخله و 3 ماه پس از شروع مداخله
    empty
    Addenbrooke's Cognitive Examination Questionnaire
    empty
    پرسشنامه معاینه شناختی ادن بروک
    empty
    #4
    Mini-Mental State Examination
    empty
    نمره معاینه کوتاه وضعیت ذهنی
    empty
    At baseline, 1 month after intervention and 3 months after intervention
    empty
    ابتدای مطالعه، 1 ماه پس از شروع مداخله و 3 ماه پس از شروع مداخله
    empty
    Mini-Mental State Examination Questionnaire
    empty
    پرسشنامه معاینه کوتاه وضعیت ذهنی
    empty

  • Intervention groups

    #1
    Intervention group: 1.5mg and 3mg rivastigmine capsules produced by Hakim Pharmaceutical Company. Rivastigmine Will be given to the patients initially 1.5mg twice daily for 2 weeks and then , 3mg twice daily per Oral until the end of the 3 month intervention period
    Intervention group: 1.5mg and 3mg rivastigmine capsules produced by Hakim Pharmaceutical Company. Rivastigmine Will be given to the patients initially 1.5mg twice daily for 2 weeks and then , 3mg twice daily per Oral to the end of the 3 months intervention period

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Taha Yahyavi
    Full name of responsible person - Persian: طه یحیوی
    Street address - English: Department of Psychiatry, Roozbeh hospital, South of Lashkar Intersection, South Kargar St
    Street address - Persian: خیابان کارگر جنوبی، پایین‌تر از چهارراه لشگر، بیمارستان روزبه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1333715914
    Phone: +98 21 5541 9151
    Fax:
    Email: hosp_roozbeh@tums.ac.ir
    Web page address: http://roozbehhospital.tums.ac.ir
    contact.organization_id:
    Name of organization / entity - English: The Institute of Pharmaceutical Sciences
    Name of organization / entity - Persian: پژوهشکده علوم دارویی
    Full name of responsible person - English: Mohammad Abdollahi
    Full name of responsible person - Persian: محمد عبداللهی
    Street address - English: Unit 1-219, 2nd floor, Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Poursina Avenue
    Street address - Persian: خیابان پورسینا، دانشگاه علوم پزشکی تهران، دانشکده داروسازی، پژوهشکده علوم دارویی، طبقه دوم، واحد 219-1
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: +98 21 66482704
    Phone: +98 21 6648 2704
    Fax: +98 21 6648 2704
    Email: TIPS@TUMS.Ac.ir
    Web page address: https://tips.tums.ac.ir/
    Tehran University of Medical Sciences
    The Institute of Pharmaceutical Sciences
    دانشگاه علوم پزشکی تهران
    پژوهشکده علوم دارویی

  • Sharing plan

    All demographic and personal information of patients, history of electroshock including the indication and number of electrocoshock sessions and their type (unilateral or bilateral, frontal or temporal), patients' underlying diseases and medications used, duration of hospitalization, The side effects observed during the study and the results of all tests are recorded in the patients record. All data, except patient contact information, can be shared after making patients unidentified, if needed.
    All demographic and personal information of patients, history of electroshock including the indication and number of electrocoshock sessions and their type (unilateral or bilateral, frontal or temporal), patients' underlying diseases and medications used, duration of hospitalization, The side effects observed during the study and the results of all tests are recorded in the patients record. All data, except patient's contact information, might be shared after making patients unidentified, if needed.
    3-6 Month after completing the study for ever
    3-6 Months after completing the study for ever
    All 3 study executives in order of priority: 1- Hossein Salimi Tel: 00989371720628 Email: hossein.salimi.1375@gmail.com 2- Fatemeh Mohammadian Rasnani Tel: 00989127907416 Email: fm4568@yahoo.com 3- Niayesh Mohebbi Tel: 00989121781476 Email: niayesh_mohebbi@yahoo.com
    All the 3 executors of the study in order of priority: 1- Niayesh Mohebbi Tel: 00989121781476 Email: niayesh_mohebbi@yahoo.com 2- Fatemeh Mohammadian Rasnani Tel: 00989127907416 Email: fm4568@yahoo.com 3- Hossein Salimi Tel: 00989371720628 Email: hossein.salimi.1375@gmail.com
    هر 3 مجری طرح به ترتیب اولویت: 1- حسین سلیمی تلفن همراه: 00989371720628 ایمیل: hossein.salimi.1375@gmail.com 2- فاطمه محمدیان رسنانی تلفن همراه: 00989127907416 ایمیل: fm4568@yahoo.com 3- نیایش محبی تلفن همراه: 00989121781476 ایمیل: niayesh_mohebbi@yahoo.com
    هر 3 مجری طرح به ترتیب اولویت: 1- نیایش محبی تلفن همراه: 00989121781476 ایمیل: niayesh_mohebbi@yahoo.com 2- فاطمه محمدیان رسنانی تلفن همراه: 00989127907416 ایمیل: fm4568@yahoo.com 3- حسین سلیمی تلفن همراه: 00989371720628 ایمیل: hossein.salimi.1375@gmail.com

Protocol summary

Study aim
Determining the efficacy of Rivastigmine on Cognitive Examination Scores. Determining the role of age & gender, patients' underlying diseases, their medications, type, number, duration, current intensity of ECT and severity of cognitive impairment and hospitalization days in that probable effect.
Design
A randomized controlled clinical trial with parallel, double-blind groups
Settings and conduct
Roozbeh Hospital, Tehran University of Medical Sciences intervention: Rivastigmine (1.5-3 mg) or placebo twice daily for 3 months Testing (Baseline, after the last ECT and 1 month then 3 months after the start of intervention) Researchers who admit patients and take tests from them and also the patients are blind. The main researcher accomplish individualized block randomization and coding.
Participants/Inclusion and exclusion criteria
Inclusion: Patients 18-70 years Patients with Biploar disorder & Schizophrenia who are candidates for Electroshock(ECT) Psychiatric diagnosis of patients based on DSM IV, SCIDP criteria Patients with refractory treatment and candidate for ECT Resistance to at least 2 antipsychotics for 6 weeks at a equivalent dose of 1000 mg chlorpromazine Patients with cognitive decline after ECT diagnosed by cognitive examinations Exclusion: Patients with heart block and arrhythmia and with a history of previous Stroke and Parkinson's disease, previous cognitive impairment or dementia and severe gastrointestinal disorders or gastrointestinal bleeding and serious medical illness present use of substances
Intervention groups
Intervention: 1.5mg and 3mg Rivastigmine capsules. Rivastigmine Will be given to the patients initially 1.5mg twice daily for 2 weeks and then, 3mg twice daily per Oral to the end of the 3 months intervention period Control: placebo twice daily for 3 months
Main outcome variables
Montreal Cognitive Assessment Addenbrooke's Cognitive Examination

General information

Reason for update
Correction of randomization blocking from 4 blocks to 2 blocks
Acronym
IRCT registration information
IRCT registration number: IRCT20200122046225N1
Registration date: 2020-05-18, 1399/02/29
Registration timing: prospective

Last update: 2020-12-12, 1399/09/22
Update count: 2
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Hossein Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4417 9132
Email address
hossein.salimi.1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-20, 1399/06/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating effects of Rivastigmine in Electroconvulsive therapy-induced cognitive side effects in patients receiving Electroshock; A Randomized double blind placebo-controled clinical trial
Public title
Effect of Rivastigmine in Electroconvulsive therapy (ECT)-induced cognitive disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over than 18 years and less than 70 years Patients with diagnosis of BMD & Schizophrenia who are candidates for ECT Psychiatric diagnosis of patients based on DSM IV, SCIDP criteria Patients with refractory treatment and candidate for ECT Resistance to at least 2 antipsychotics for 6 weeks at a equivalent dose of 1000 mg chlorpromazine Patients with cognitive decline with electroshock diagnosed by neuroscientist and under cognitive evaluation by ACE, MoCA
Exclusion criteria:
Patients with a history of previous neurologic disease include Stroke and Parkinson's disease Patients with a history of previous cognitive impairment and dementia Patients with heart block and arrhythmia Patients with a history of severe gastrointestinal disorders and gastrointestinal bleeding History of serious medical illness present use of substances
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Individual Block Randomization with 2 blocks in two groups of intervention and control To conceal the allocation as well as to preserve blindness, an out-of-field researcher prepares random sequences of patients and encodes each patient's medication packages prior to initiating the patient selection. The medicines and placebo tablets, which are quite similar in appearance, are poured into the same cans. All pills required for each patient during the study are packed in 3-digit coded cans. The list of patient selection based on these three-digit codes is also provided to the researcher based in the field. All clinical evaluations will also be performed by another researcher who is in the field and not involved in the allocation process.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double blinded study. The main researcher accomplish the coding for the drugs and is aware of the drug or the placebo, but he remains blind to which patient takes which drug package code. Researchers who admit patients and take cognitive assessment tests, and the data analyst as well as the patients, become blind to the allocation and study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Apartment No 3, No 4, East 24th Avenue, South Laleh Street, West Naser Hejazi Blvd
City
Tehran
Province
Tehran
Postal code
1484914164
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.TUMS.TIPS.REC.1398.134

Health conditions studied

1

Description of health condition studied
ECT, Electroconvulsive therapy, Electroshock, ECT-induced Cognitive Disorders, ECT-induced Memory Disorder, Rivastigmine, Cholinesterase Inhibitors, MoCA, ACE, Effect of Rivastigmine on Cognitive Impairment After ECT, Effect of cholinesterase inhibitiors on cognitive impairments after electroconvulsive therapy, effect of Rivastigmine on memory
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Montreal Cognitive Assessment Score
Timepoint
Before receiving the first ECT session, after receiving the last session and 1 month after the beginning of intervention and finally 3 months after that
Method of measurement
Montreal Cognitive Assessment Test Questionnaire

2

Description
Addenbrooke's Cognitive Examination Score
Timepoint
Before receiving the first ECT session, after receiving the last session and 1 month after the beginning of intervention and finally 3 months after that
Method of measurement
Addenbrooke's Cognitive Examination Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1.5mg and 3mg rivastigmine capsules produced by Hakim Pharmaceutical Company. Rivastigmine Will be given to the patients initially 1.5mg twice daily for 2 weeks and then , 3mg twice daily per Oral to the end of the 3 months intervention period
Category
Treatment - Drugs

2

Description
Control group: receiving placebo twice daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Fatemeh Mohammadian Rasnani
Street address
Roozbeh hospital, South of Lashkar Intersection, South Kargar St
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
hosp_roozbeh@tums.ac.ir
Web page address
http://roozbehhospital.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Ghahremani
Street address
Research office, Jadid building, Tehran Pharmacy School, 16 Azar St, Keshavarz Blvd
City
tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 9102
Email
mhghahremani@tums.ac.ir
Web page address
http://pharmacy.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
20
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

2

Sponsor
Name of organization / entity
The Institute of Pharmaceutical Sciences
Full name of responsible person
Mohammad Abdollahi
Street address
Unit 1-219, 2nd floor, Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Poursina Avenue
City
Tehran
Province
Tehran
Postal code
+98 21 66482704
Phone
+98 21 6648 2704
Fax
+98 21 6648 2704
Email
TIPS@TUMS.Ac.ir
Web page address
https://tips.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Institute of Pharmaceutical Sciences
Proportion provided by this source
80
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
Hossein Salimi
Position
Student of Pharm-D
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Apartment No 3, No 4, East 24th Avenue, South Laleh Street, West Naser Hejazi Blvd
City
tehran
Province
Tehran
Postal code
1484914164
Phone
+98 21 4417 9132
Email
hossein.salimi.1375@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadian Rasnani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Apartment No 3, No 4, East 24th Avenue, South Laleh Street, West Naser Hejazi Blvd
City
tehran
Province
Tehran
Postal code
1484914164
Phone
+98 21 4417 9132
Email
fm4568@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Salimi
Position
Student of Pharm-D
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Apartment No 3, No 4, East 24th Avenue, South Laleh Street, West Naser Hejazi Blvd
City
Tehran
Province
Tehran
Postal code
1484914164
Phone
+98 21 4417 9132
Email
hossein.salimi.1375@gmail.com

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
Yes - There is a plan to make this available
Title and more details about the data/document
All demographic and personal information of patients, history of electroshock including the indication and number of electrocoshock sessions and their type (unilateral or bilateral, frontal or temporal), patients' underlying diseases and medications used, duration of hospitalization, The side effects observed during the study and the results of all tests are recorded in the patients record. All data, except patient's contact information, might be shared after making patients unidentified, if needed.
When the data will become available and for how long
3-6 Months after completing the study for ever
To whom data/document is available
Academic researchers & professors and also independent researchers
Under which criteria data/document could be used
Only analyzes related to the published results of the study (the effect of Rivastigmine on cognitive impairments only after Electroconvulsive therapy and the possible altering factors on this effect recorded in this study) In order to access the data, a full introduction of the applicant with a valid document and an explanation of the intention to access the information is necessary. the applicant will need to guarantee that he/she use the information only to the claimed intension.
From where data/document is obtainable
All the 3 executors of the study in order of priority: 1- Niayesh Mohebbi Tel: 00989121781476 Email: niayesh_mohebbi@yahoo.com 2- Fatemeh Mohammadian Rasnani Tel: 00989127907416 Email: fm4568@yahoo.com 3- Hossein Salimi Tel: 00989371720628 Email: hossein.salimi.1375@gmail.com
What processes are involved for a request to access data/document
It is necessary to mention the cause and purpose of the use of information. applicant need to guarantee that will not disclose the data by invalid methods of analysis. If we confirm the request, the requested information will be sent within 2 to 4 weeks.
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