]>
IRCT20220516054879N5 IRCT 2023-05-27 Gerash University of Medical Sciences Effect of Melatonin on Cognitive Performance Impairment The Effect of Melatonin on Cognitive Performance Impairment During Electro Convulsive Therapy in Patients with Bipolar Disorder 2023-05-26 anticipated 46 Complete https://irct.ir/trial/70191 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The case group was named A and the control group was named B. Random blocking is in this way that research units were assigned number 1 to 46 in order. Then a table with 23 rows named block and each block had 2 parts and each part was labeled with A and B was named, considered. In the next step, the numbers will be placed in each house in order. After all the numbers were placed in the blocks, the people who had numbers in house A received the intervention drug, and the people who had numbers in house B, they were considered as the control group. The website https://www.sealedenvelope.com is used for randomization. The treatment group of each patient will be determined only after randomization. Allocation Concealment method: Opaque envelopes sealed with a random sequence (snose) are used, Blinding description: The treatment group of each patient will be determined only after randomization. The participants and the medical doctors responsible for taking care of the health of the patients and the researcher will be blinded and will not know about the treatment group. Only the ward nurse will be aware of the patient's treatment group and will open the relevant envelope. In addition, the research evaluators and statistics experts will be blinded to the treatment group of patients. In order to hide the random allocation, the Numbered Sequentially Envelopes method is used: envelopes sealed, opaque. 3 Bipolar. Intervention 1: Intervention group: 23 Patients in the intervention group will receive 3 mg melatonin tablets manufactured by Simorgh Daru Company in the form of 1 oral tablet 2 times a day from 24 hours before the start of ECT to 24 hours after the end of ECT. Intervention 2: Control group:23 Patients in the control group will receive placebo tablets manufactured by Simorgh Daru Company in the form of 1 oral tablet 2 times a day from 24 hours before the start of Electroconvulsive Therapy to 24 hours after the end of Electroconvulsive Therapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the approval of the ethics committee of Guilan University of Medical Sciences, in order to respect the privacy of patients, there is no plan to publish the results of patients.
public Maryam Shahrokhi
17 Shahrivar Hospital, Shahid Siadati Street, Namjoo Street, Rasht
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences scientific Maryam Shahrokhi
17 Shahrivar Hospital, Shahid Siadati Street, Namjoo Street, Rasht
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age who are diagnosed with bipolar according to Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria and based on the diagnosis of a psychiatrist, and at the beginning of ECT treatment, refer to Rasht Shafa Hospital. 18 years no limit Both Schizophrenia Drug Abusers Psychiatric diseases with other mental illnesses Bradyarrhythmia Liver or kidney failure History of seizures Drug or alcohol use History of asthma or bronchospasm History of allergy to melatonin Pregnancy Breastfeeding Currently uncontrolled hypertension Active peptic ulcer Receiving nitroglycerin History of severe skin disease such as Steven Johnson. F31 Bipolar disorder Treatment - Drugs Placebo Intervention group: 23 Patients in the intervention group will receive 3 mg melatonin tablets manufactured by Simorgh Daru Company in the form of 1 oral tablet 2 times a day from 24 hours before the start of ECT to 24 hours after the end of ECT. Control group:23 Patients in the control group will receive placebo tablets manufactured by Simorgh Daru Company in the form of 1 oral tablet 2 times a day from 24 hours before the start of Electroconvulsive Therapy to 24 hours after the end of Electroconvulsive Therapy. The primary measurable outcome in this study is the evaluation of cognitive disorders caused by electroshock therapy in bipolar patients treated with melatonin by the Mini-Mental State Examination questionnaire, which is evaluated before and after 12 sessions of electroshock therapy. Timepoint: Before and after 12 sessions of electroshock therapy. Method of measurement: Mini-Mental State Examination questionnaire. The examination of changes in systolic and diastolic blood pressure. Timepoint: Before and after each session. Method of measurement: The blood pressure of the patients are checked and measured by the doctor and the researcher every time the patient visits. Check heart rate changes. Timepoint: Before and after each session. Method of measurement: The heart rate of the patients is checked and measured by the doctor and the researcher every time the patient visits. Investigation of possible drug side effects. Timepoint: Before and after each session. Method of measurement: Patients are examined by doctors and researchers at each visit. Gerash University of Medical Sciences Approved 2023-05-03 Ethics Committee of Guilan University of Medical Sciences Rasht, Namjo St., Shahid Siadati St., in front of 17 Shahrivar Hospital, Research and Technology Deputy Rasht Guilan Iran (Islamic Republic of)