A comparative study of the effectiveness of injectable phenytoin and oral sodium valproate in the acute phase of mania in bipolar patients

Determining the effectiveness of injectable phenytoin and oral sodium valproate in the acute phase of mania in bipolar patients

Clinical trial with control group, with parallel groups, blinded, randomized, phase 2 on 70 patients. The rand function of Excel software was used for randomization

Ibn Sina Hospital of Mashhad will be conducted on 70 patients aged 18-40 with bipolar disorder in the acute phase of mania. The disease was diagnosed based on the diagnostic criteria of DSM-5 and the severity of the symptoms will be evaluated on the day of hospitalization and daily during one week of the start of injectable drug treatments.

1. Patients with bipolar disorder in an episode 2. Patients in the age range of 18 to 40 3. Absence of pregnancy and postpartum period 4. Not having medical illness, especially convulsions Exclusion criteria: sensitivity to drug treatment

The first group of injectable phenytoin drug will receive an initial dose of 10 mg/kg followed by 100 mg intravenously over 50 minutes every 8 hours and the second group will receive oral sodium valproate at a dose of 20 mg/kg daily for two weeks.

Patients' symptoms based on daily visits and YMRS, CGI tests

70 patients are randomized in a simple way using a table of random numbers (to use the table of random numbers, first the framework of the statistical community is determined (70 people); respectively, we give them a code or serial number. Codes and numbers It should be equal to that assigned to the members of society; for example, in our research, we give two-digit codes to people, such as 01, 02, 03, ..., 11, 12, .... To select sample people from the table, we randomly start from a point in the table in the row or column direction. We can choose the point by closing our eyes and placing a finger or the tip of a pen on the table. Moving in the direction of row or column does not differ and this is optional. But according to the type of code digits (one digit, two digit, three digit, etc.), we must choose the same number of digits in the direction of row or column. After this, we control the route numbers. Whether we like it or not, we will come across two types of numbers, one type of which is smaller than the number of the studied community and the other type is larger than the number of the community. We should pay attention to and choose only the smaller numbers. The selected number is actually the code of an individual from the community that is selected as a sample. This work should continue until the number of sample people can be chosen as small as possible. After the sample volume is complete, the sampling work ends. The numbers will be placed in sealed envelopes, and when the participants enter, an envelope will be assigned to each of them, and they will be placed in one of the 2 intervention groups.