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IRCT20160523028008N26 IRCT 2022-09-13 Hamedan University of Medical Sciences The effect of adding omega-3 in bipolar patients during manic period requiring ECT. The effectiveness of omega-3 adjuvant therapy to Electroconvulsive therapy (ECT) in bipolar patients in a manic episode 2022-08-23 anticipated 50 Complete https://irct.ir/trial/65234 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The form of the drug and the placebo are completely the same, so the patient and the examining physician will not be aware of the patient's type of drug treatment, so the study will be performed in a double-blind manner. 2-3 Bipolar Disorder, current episode manic severe with psychotic features. Intervention 1: Intervention group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with 100 mg omega-3 capsules (manufactured by Zahravi company) as a single daily oral dose for 4 weeks. The number of electroshock therapy sessions is 8 sessions, which are done on a day in the middle under standard conditions. Intervention 2: Control group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with a placebo (manufactured by Zahravi company) for 4 weeks. The number of electroshock therapy sessions is 8 sessions, which are done on a day in the middle under standard conditions. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not a plan to make this available
public Khadijeh Arabloo
Farshchian Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 1828 5015 Kharabloo1358@gmail.com Hamedan University of Medical Sciences scientific Ali Ghaleiha
Farshchian Hospital, Mirzadeh Eshghi Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 1828 5015 alighaleih@yahoo.co.uk Hamedan University of Medical Sciences Iran (Islamic Republic of) Bipolar patients in the acute phase of mania who, according to the physician, needed ECT Age greater than or equal to 18 Young Mania Rating Scale greater than or equal to 20 Having at least fifth grade education 18 years 65 years Both Psychiatric disorders except Bipolar Disorder Pregnancy or breastfeeding Having a history of substance abuse in the last 2 weeks or addiction in the last 2 months Having a systemic disease F31.2 Bipolar Disorder, current episode manic severe with psychotic features Treatment - Drugs Placebo Intervention group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with 100 mg omega-3 capsules (manufactured by Zahravi company) as a single daily oral dose for 4 weeks. The number of electroshock therapy sessions is 8 sessions, which are done on a day in the middle under standard conditions. Control group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with a placebo (manufactured by Zahravi company) for 4 weeks. The number of electroshock therapy sessions is 8 sessions, which are done on a day in the middle under standard conditions. Mania symptoms. Timepoint: Before the intervention, after the fourth and eighth sessions of ECT. Method of measurement: Young Mania Rating Scale (YMRS). Cognitive function. Timepoint: Before and after the intervention. Method of measurement: Cognitive function Test by using Montreal Cognitive Assessment. Sleep quality. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality Index. Hamedan University of Medical Sciences Approved 2022-06-25 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)