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IRCT20190525043700N3 IRCT 2021-03-12 Babol University of Medical Sciences The effectiveness of thiamine on cognitive symptoms after electroconvulsive therapy in patients with mood disorders Effect of thiamine on cognitive symptom in the patients with mood disorder in the depression phase under electroconvulsive therapy (clinical trial- double blind) 2021-03-10 anticipated 62 Complete https://irct.ir/trial/54770 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients randomly divided into two groups of 31 subjects with four blocks and an allocation ratio of 1: 1.The free website WWW.randomization .com was used to generate the allocation sequence. The obtained sequence was written on separate sheets and placed in sealed envelopes and given to the main researcher for study, Blinding description: Thiamine tablets are powdered by a mortar and the placebo is filled with flour and poured into separate capsules. The shape, taste, smell and packaging of the drugs are quite similar. A code is assigned to each container of medicine. When the drug is assigned to the patient, the drug code will be entered on the file. At the end of the study, the codes will be opened and the results will be analyzed. 3 Cognitive Symptom. Intervention 1: Intervention group: Thiamine (pharmaceutical drug Sanamod) will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks. Intervention 2: Control group: Placebo will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is still no plan for its publish.
public Romina Hamzehpour
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 r.hamzehpour@mubabol.ac.ir Babol University of Medical Sciences scientific Romina Hamzehpour
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 r.hamzehpour@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Patients aged 20-50 years with depressive phase of mood disorders 20 years 50 years Both Patients with a history of alcohol and other substance use in the month before enrollment Epilepsy Mental retardation Cognitive disorders such as delirium and dementia History of thiamine use in the month before enrollment Anemia Malnutrition R41 Other symptoms and signs involving cognitive functions and awareness Treatment - Drugs Treatment - Drugs Intervention group: Thiamine (pharmaceutical drug Sanamod) will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks Control group: Placebo will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks Cognitive ability. Timepoint: It will be measured 24 hours before and 24 hours after the end of electroconvulsive therapy sessions and also two months after the end of electroconvulsive therapy. Method of measurement: Addenbrooke's Cognitive Examination. Babol University of Medical Sciences Approved 2021-02-20 Ethics committee of Babol University Of Medical Sciences Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)