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IRCT20201026049152N1 IRCT 2020-11-28 Ahvaz University of Medical Sciences Comparison of The Effect of Modafinil and Citalopram On The Treatment of Major Depression Comparison of The Effect of Modafinil and Citalopram On The Treatment of Major Depression 2020-11-21 anticipated 30 Complete https://irct.ir/trial/51928 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. The main idea of ​​block randomization is to divide patients into M blocks of size 2N, so that in each block N patients are assigned A and patients N are assigned to B. 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 block size should be at least twice the number of treatment nodes. 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 disclosure of block mechanism (2) Use of random block size In both groups, the drugs will be given to the patients in the same way and they will receive the medicine 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 Professor) Drug packages are completely similar in shape and the patient and the project manager are not aware of the contents of the packages. In addition, collecting information, assessing patients and completing the forms is done by the project manager and his assistant who are not aware of the contents of the packages. ; In the data analysis stage, the analysis 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 1 or 2) will be identified for data analysis; Therefore, the study is three way blind and the contents of the two drug groups are not clear from the stage of the patient entering the study to conduct the study, data collection and analysis of information. 3 Major depressive disorder. Intervention 1: Intervention group: This group receives 200 mg of modafinil (2 of 100 mg tablets made in Iran) every morning and will be re-evaluated by Hamilton Depression Inventory three weeks and six weeks after the start of the intervention. Intervention 2: Control group: This group receives two 20 mg citalopram tablets made in Iran, which have been standardized with modafinil, equivalent to 40 mg citalopram every day, and will be re-evaluated by Hamilton questionnaire three weeks and six weeks after the start of the intervention. 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 more information.
public Golsa Safaei
No 14,Maryam Alley,East Sorush St,East Kianpars St
Ahvaz Iran (Islamic Republic of) 6155686395 +98 61 3333 6894 Golsa.safaei@gmail.com Ahvaz University of Medical Sciences scientific Golsa Safaei
No 14,Maryam Alley,East Sorush St,East Kianpars St
Ahvaz Iran (Islamic Republic of) 6155686395 +98 61 3333 6894 Golsa.safaei@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 65 years Diagnosis of clinical Major Depressive Disorder based on the DSM5 criteria A score above 25 on the Hamilton Depression Rating Scale Written consent to enter the study from the patient or her /his guardian The patient is able to take medicine 18 years 65 years Both Depression caused by physical illness or the use of drugs and substances Existence of any severe and chronic physical illness (brain, cardiovascular disease, seizure or history of substance abuse) History of gastric ulcer Pregnancy History of alcohol use and substance abuse during the 6 months prior to the start of the project History of manic episodes Intellectual disorders Psychosis Breastfeeding High severity of depression such as melancholic and suicidal ideation History of receiving antidepressant in two to four weeks before starting the drug (eg MAOIs in the last four weeks but SSRIs or mirtazapine or SNRIs in the last two weeks) History of non-response or shifting with the studied drugs History of receiving lithium, lamotrigine, sodium valproate, atypical antipsychotics available other than ziprasidone and aripiprazole, in the past two weeks or one month (depending on the half-life of the drug or based on similar studies) Being treated with Ritalin for any reason Existence of mixed symptoms in the recent episode Existence of anxiety disorder, especially panic F32 Major depressive disorder, single episode Treatment - Drugs Treatment - Drugs Intervention group: This group receives 200 mg of modafinil (2 of 100 mg tablets made in Iran) every morning and will be re-evaluated by Hamilton Depression Inventory three weeks and six weeks after the start of the intervention. Control group: This group receives two 20 mg citalopram tablets made in Iran, which have been standardized with modafinil, equivalent to 40 mg citalopram every day, and will be re-evaluated by Hamilton questionnaire three weeks and six weeks after the start of the intervention. Depression score on the Hamilton questionnaire. Timepoint: At the beginning of the study and three weeks and six weeks after the start of the intervention. Method of measurement: The Hamilton questionnaire. Ahvaz University of Medical Sciences Approved 2020-02-01 Ethics Committee of Jondishapur University of Medical Sciences Ethics Committee Center,Golestan Hospital,Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)