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IRCT20200207046404N1 IRCT 2020-04-23 Sanandaj University of Medical Sciences Efficacy of galantamine on cognitive performance Efficacy of galantamine on cognitive performance of patients under electro convulsive therapy 2018-10-01 anticipated 75 Complete https://irct.ir/trial/45668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random assignment of the patients into two intervention or control groups,patients are randomly divided into two groups A and B with a table of random numbers (random numbers table is a collection of numbers that are generated without a specific pattern or order and completely randomized then samples are randomly selected by randomizer software).The numbers are given to the pharmacist, based on which he determines the medicinal packages of galantamine and placebo and no one but him knows which drug and which placebo it is, and the number of each package is recorded in the patient's file, Blinding description: Packages containing medications were prepared by pharmacist and nobody knew their content except the pharmacist. Patients names were randomly assigned into blocks A and B based on random number table insert on the drug envelops and were given medication packages until the end of the study. 3 Condition 1: Schizophrenia. Condition 2: Schizoaffective. Condition 3: Mood disorders. Condition 4: Obsessive- compulsive disorders. Intervention 1: Galantamin 4mg capsules BID in the intervention group until the end of ECT treatment.(for 15 days). Intervention 2: Control group: received placebo capsules BID until the end of ECT treatment.(for 15 days). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No More Information
public Hojat Esfandiyary
Pasdaran Ave
Sanandaj Iran (Islamic Republic of) 986617713446+ +98 87 3362 6968 Esfandyari@gmail.com Sanandaj University of Medical Sciences scientific Azizalah Ghanbari
Pasdaran ave
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3362 6968 Ravanmehr20@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Patients aged between 18-60 years Patients or their legal guardian must sign an informed consent form Number of sessions of ECT between 4-8 18 years 60 years Both Alcohol & drug abuse or dependence Renal failure Ischemic heart disease Stroke in last 6 months Delirium &Dementia Pregnancy & Lactation History of using Galantamine in past 3 months Galantamine sensitivity Mental retardation F20 F25 F06.34 F42 Schizophrenia Schizoaffective disorders Mood disorder due to known physiological condition with mixed features Obsessive-compulsive disorder Prevention Placebo Galantamin 4mg capsules BID in the intervention group until the end of ECT treatment.(for 15 days) Control group: received placebo capsules BID until the end of ECT treatment.(for 15 days) Memory. Timepoint: 1day before begining and after session 3 and after the electroconvulsive therapy. Method of measurement: Wechsler, mini mental statuse examination. Nausea. Timepoint: During intervention( once a day for 15 days). Method of measurement: Patient self report. Confusion. Timepoint: During intervention(once a day for 15 days). Method of measurement: Patient self report. Dizziness. Timepoint: During intervention(once a day for 15 days). Method of measurement: Patient self report. Sanandaj University of Medical Sciences Approved 2018-07-03 Ethics Committee of Kurdestan University of Medical Sciences Kurdestan Medical Sciences Univercity,Pasdaran Ave, Sanandaj Town Sanandaj Kurdistan Iran (Islamic Republic of)