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

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.

A randomized controlled clinical trial with parallel, double-blind groups

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.

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: 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

Montreal Cognitive Assessment Addenbrooke's Cognitive Examination

Correction of randomization blocking from 4 blocks to 2 blocks

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.

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.

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 Months after completing the study for ever

Academic researchers & professors and also independent researchers

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.

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

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.