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IRCT20231022059813N1 IRCT 2023-12-14 Hamedan University of Medical Sciences Comparison of the effect of risperidone and aripiprazole in the treatment of the acute phase of mania Comparison of the effect of risperidone and aripiprazole as a clinical trial in treating the acute phase of mania in patients with bipolar disorders 2023-11-22 anticipated 76 Complete https://irct.ir/trial/73366 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, volunteers will be assigned to two groups by simple randomization method. The drugs used are delivered to the patients in a similar form and appearance. Coding of the intervention groups is done by one of the experts of the psychiatric department of the hospital, and the research group will be unaware of the coding until the end of the research. In order to randomize people into two groups, calculator.net online software generated 76 random numbers between the numbers 1 and 76, and the numbers generated in the range {1-38} were assigned to the control group and the numbers generated in the range {39-76} were assigned to the intervention group, which is shown in the following sequence: BBBABBBBBBAAAABBAABBAABBBAAAABABAAABBBABAAABBBBBBBAAAAABBABABAAABBBBABAAAAAAA, Blinding description: The used drugs are delivered to the mentioned patients in a similar form and appearance. Coding of the intervention groups will be done by one of the experts of the psychiatric department of the hospital, and the research group (participant and clinical caregiver and researcher and outcome evaluator) will be unaware of the coding until the end of the research. 3 Comparison of the effect of risperidone and aripiprazole as a clinical trial in treating the acute phase of mania in patients with bipolar disorders. Intervention 1: Intervention group 1: Resperidone 2 mg tablet of Biopharma company once a night and sodium valproate tablet of Raha company 500 mg a night orally for two weeks. Intervention 2: Intervention group 2: Aripiprazole 10 mg tablet of Sobhan Shabi company and sodium valproate tablet of Raha company 500 mg once orally during two weeks. 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 There is no further information
public Seyed Mustafa Mousavi
Nasser Khosro Street, Shahid Timuri Street, Yadgar Imam Som Alley
Khorramabad Iran (Islamic Republic of) 6816947174 +98 66 3320 5264 dr.mousavi1988@gmail.com Hamedan University of Medical Sciences scientific Seyed Mustafa Mousavi
Nasser Khosro Street, Shahid Timuri Street, Yadgar Imam Som Alley
Khorramabad Iran (Islamic Republic of) 6816947174 +98 66 3320 5264 dr.mousavi1988@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patient consent to participate in the study Suffering from the acute phase of mania of bipolar disorder, which must be confirmed by a psychiatrist no limit no limit Both History of sensitivity and allergy to aripiprazole and risperidone Physical illness Treatment - Drugs Treatment - Drugs Intervention group 1: Resperidone 2 mg tablet of Biopharma company once a night and sodium valproate tablet of Raha company 500 mg a night orally for two weeks Intervention group 2: Aripiprazole 10 mg tablet of Sobhan Shabi company and sodium valproate tablet of Raha company 500 mg once orally during two weeks Comparison of risperidone and aripiprazole in the treatment of manic phase of bipolar disorder. Timepoint: The beginning of the study and 7 and 14 days after the beginning of the mania phase. Method of measurement: Jung's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in increasing energy. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in elevated mood. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in increasing libido. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in sleep disorder. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in irritability. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in talkative speech. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in thought disorder. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in Thought content disorder. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in aggression. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in appearance beauty. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Comparison of risperidone and aripiprazole in disease insight. Timepoint: At the beginning of the study and 7, 14 days after starting to take the drug. Method of measurement: Yang's Mania Rating Questionnaire. Hamedan University of Medical Sciences Approved 2023-07-18 Ethics Committee of Hamadan University of Medical Sciences Nasser Khosrokh Street, Shahid Timuri Street, Yadgar Imam Som Alley Khorramabad Lorestan Iran (Islamic Republic of)