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IRCT20200913048698N1 IRCT 2020-12-12 Ahvaz University of Medical Sciences Comparison of Venlafaxine and Bupropion on depression of Bipolar II disorder Comparison of effect of Venlafaxin and Bupropion in treatment of Depressive episode of Bipolar II disorder 2020-12-10 anticipated 60 Complete https://irct.ir/trial/51641 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used.A computer algorithm written in SAS (Statistical Analysis System) is used for performing a block randomization with randomaly selected block size of 4, 8 and 12. Example out put from the SAS algorithm; Block 1; size;4 1. 4. Control 2. 4 Control 3. 4 Intervention 4. 4. Intervention Block 2; size ;4 1. 4 Control 2. 4. Intervention 3. 4 Control 4. 4. Intervention Block 3; size ;8 1. 8. Control 2. 8. Intervention 3. 8. Control 4. 8. Intervention 5. 8. Intervention 6. 8 Intervention 7. 8 Control 8. 8. Control The main idea of block randomization is to divide patients into M blocks of size 2N, so that in eachblock N patients are assigned to control group and N patients are assigned to intervention group.The selection of blocks is based on individual characteristics. The block is then randomly selected. This method ensures equal treatment allocation per block provided the block is fully utilized. The size of the block, depending on the number of treatments, should be short enough to prevent imbalance, and large enough to prevent guessing treatment allocation in each group during the study. The size of the block should be at least twice the number of treatment groups. The size of the block is not stated in the study so that researchers are blind to it. If the blocks are expressed, the treatment series in each block can be guessed. This can lead to selection bias. The solution to prevent this error is to: (1) Lack of disclose the block mechanism (2) Use random block size. In each group, the drugs will be given to the patients in the same way, and the drug will be found on the same days and in the same way. Everyone on the research team, like patients and their families, will be unaware of the treatment groups designed, Blinding description: Patients are treated with medication packages pre-determined by the study supervisor (supervisor).Drug packages are quite similar in shape.The patient and the facilitator are not aware of the contents of the packages. In addition, collecting patient assessment information and completing forms is done by the project manager and his assistant who are not aware of the content of the packages.The data analysis stage will be performed by the project consultant and the project manager who are not aware of the contents of the drug packages and only the group of patients (group one or two) will be identified for data analysis, so the study is three-blind.And from the stage of patient admission to the study, data collection and data analysis of the contents of the two drug groups is not clear. 2-3 Bipolar II disorder. Intervention 1: Intervention group: This group receives 75 mg Bupropion tablets made in Iran equivalent to 75 mg every morning and re-evaluated by Hamilton Depression Inventory two weeks, three weeks and four weeks after the start of the intervention. Intervention 2: Control group: This group receive Venlafaxine 75 mg tablet made in Iran, has been standardized with bupropion, equivalent to 75 mg daily, and after two weeks, three weeks and four weeks from the start of the intervention by the Hamilton questionnaire is re-evaluated. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific centers are allowed to request documents for scientific use Where to obtain: Hamze Rostami; Rostami-h@ajums.ac.ir; 0098 3112848;Ahmad fakhri; fakhri_a@ajums.ac.ir; Khatere Asadi; dr.kh.asadi@gmail.com; Golestan hospital; Ahwaz; Fax:0098 6133743038 How to obtain: Researchers working in academic and scientific centers should send a request for documents to the above address, the files will be sent as soon as possible Comments:
public Khatere Asadi
Golestan Alley
Ahwaz Iran (Islamic Republic of) 61357-33118 +98 61 3374 3038 dr.kh.asadi@gmail.com Ahvaz University of Medical Sciences scientific Hamze Rostami
Golestan Alley
Ahwaz Iran (Islamic Republic of) 61357-33118 +98 61 3374 3038 Rostami@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Depressive episode of Bipolar II disorder according to DSM V Ability to take oral medication informed consent from the patient or parents The patient has not used another antidepressant within four weeks of starting the drug 18 years no limit Both Sucidal tought Psychosis The current episode is mixed Rapid cycling Dyspepsia or peptic ulcer Pregnant and lactating women Intellectual disabilitie History of alcohol and substance abuse up to six months before the start of the project The patient's depression is caused by a physical illness using drugs or medication Existence of any severe and chronic physical illness, cerebrovascular disease, seizures or history of substance use Psychotic depression F31.81 Bipolar II disorder Treatment - Drugs Treatment - Drugs Intervention group: This group receives 75 mg Bupropion tablets made in Iran equivalent to 75 mg every morning and re-evaluated by Hamilton Depression Inventory two weeks, three weeks and four weeks after the start of the intervention. Control group: This group receive Venlafaxine 75 mg tablet made in Iran, has been standardized with bupropion, equivalent to 75 mg daily, and after two weeks, three weeks and four weeks from the start of the intervention by the Hamilton questionnaire is re-evaluated. Depression Score Hamilton Questionnaire. Timepoint: Depression score of Hamilton questionnaire is calculated before intervention, and 14, 21 and 28 days after intervention. Method of measurement: Hamilton Questionnaire. Hypo mania score with MDQ questionnaire. Timepoint: Before starting the intervention. Method of measurement: MDQ Questionnaire. Ahvaz University of Medical Sciences Approved 2020-02-09 Ethics committee of Ahvaz University of Medical Sciences Golestan hospital., Golestan alley Ahvaz Khouzestan Iran (Islamic Republic of)