Investigating the effect and side effects of bupropion on fatigue, disability and quality of life of multiple sclerosis patients

Investigating the effect and side effects of bupropion on fatigue, disability and quality of life of multiple sclerosis patients

A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 100 patients. Blocks of four will be used for randomization.

This study is a randomized clinical trial (blocks of four), double blind (participants and results analyzer), with parallel groups, without a control group and with the participation of 80 patients with multiple sclerosis referred to Imam Reza Hospital (Tabriz). will be done. In this study, the effects and complications of bupropion in patients will be investigated.

The most important criteria for entering the study include a definitive diagnosis of multiple sclerosis based on the MacDonald criteria, 2017 version, and an EDSS value of less than four, and the most important exclusion criteria include: the use of drugs that have a reducing or intensifying effect on fatigue, such as dalfampridine, modafinil, anti Depressants and other psychiatric drugs and the use of other auxiliary methods such as herbal medicines, antidepressants, yoga, unnecessary supplements, addiction or drug use.

In this study, patients who will refer to the doctor due to multiple sclerosis will undergo intervention. Patients will be randomly divided into two groups. For one group, along with routine treatments, Bupropion drug will be prescribed and for another group, placebo drug will be prescribed along with routine drugs, and finally, the level of fatigue and quality of life will be compared in them.

Quality of life

In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will divid into two intervention groups (group A) and control group (group B).

The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of technique used, in this study they will not know what type of technique will be used in other patients.