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IRCT20101130005280N39 IRCT 2021-07-31 Mashhad University of Medical Sciences Evaluation the effect of levothiracetam in bipolar disorder Comparsion of the efficacy oral levetiracetam and injection levetiracetam in the acute mania in bipolar disorders 2021-07-23 anticipated 40 Complete https://irct.ir/trial/57550 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two intervention groups, Blinding description: In this study only analyzer, the one who analyzes the outcome, is not aware of the group of patients. 3 Bipolar disorder. Intervention 1: Intervention group: In this group, levotiracetam is diluted at a dose of 500 mg per 100 ml of normal saline, dextrose or ringer. It is injected every 12 hours for 15 minutes and given for 7 days, then oral levotiracetam treatment will be continued for another 7 days. Intervention 2: Intervention group: In the second intervention group, oral levothiracetam 500 mg every 12 hours for 14 days is given to bipolar patients. 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 In order to publish the data, the necessary colleagues should be consulted after completion of the work
public Ali Akhoond poor Manteghi
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
Mashhad Iran (Islamic Republic of) 91959 83134 +98 51 3711 2709 Manteghia@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Akhoond poor Manteghi
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
Mashhad Iran (Islamic Republic of) 91959 83134 +98 51 3711 2709 Manteghia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient has no other psychiatric disorder or problem. Patients with bipolar disorder in the mania phase between 18 to 40 years old 18 years 40 years Both shock therapy during the past year. Pregnancy and breastfeeding F31 Bipolar disorder Treatment - Drugs Treatment - Drugs Intervention group: In this group, levotiracetam is diluted at a dose of 500 mg per 100 ml of normal saline, dextrose or ringer. It is injected every 12 hours for 15 minutes and given for 7 days, then oral levotiracetam treatment will be continued for another 7 days. Intervention group: In the second intervention group, oral levothiracetam 500 mg every 12 hours for 14 days is given to bipolar patients Intensity of mania. Timepoint: At the beginning of the study (before the intervention) and after the treatment period. Method of measurement: YMRS (Young Mania Rating Scale) questionnaire. Cognitive function. Timepoint: At the beginning of the study (before the intervention) and after the treatment period. Method of measurement: Stroop Questionnaire. Mashhad University of Medical Sciences Approved 2021-02-09 Ethics Committee of Mashhad University of Medical Sciences Daneshgah street, Ghoreishi building Mashhad Razavi Khorasan Iran (Islamic Republic of)