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IRCT20200513047429N1 IRCT 2020-06-28 Tehran University of Medical Sciences Comparison Bupropion with srtraline on the depression in Parkinson Comparison of the effect of Bupropion with sertraline on the treatment of depression in Parkinson patients. 2020-06-09 anticipated 42 Complete https://irct.ir/trial/48186 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our study is a randomized double-blind trial. Both patients and assessors will be unaware of the type of intervention for each patient.For randomization, we will use the simple randomization method, and for this purpose, Random number table will be used. First, the researcher predetermines the table to read the numbers (eg, top, bottom, left, or right), and the researcher also specifies how the numbers will be assigned to the two intervention groups ((For example, odd numbers for the Bupropion group and even numbers for the sertraline group). The researcher then touches one of the numbers and moves in one of the predefined directions, recording the numbers and assigning them to different groups. A nurse who is not involved in the intervention and delivery of the results, and delivers the medicine to the patient based on the patient's membership, Blinding description: Medications are given to a patient in a packet without medication information. Any subsequent follow-up of the patient will be performed by a physician who is unaware of the patient's membership. 4 Condition 1: Depression. Condition 2: Parkinson. Intervention 1: Intervention group 1: Depressed Parkinson's patients will be prescribed Bupropion tablets at an initial dose of 75 mg daily, and if there is no initial response after one month, the dose will be increased to 150 mg daily. The above drug is manufactured by Abidi Pharmaceutical Company. Intervention 2: Intervention group: Depressed patients with Parkinson's disease, Sertraline at a dose of 50 mg daily, and if there is no initial response after one month, an increase in dose to 100 mg daily will be prescribed. It is an drug from Abidi Pharmaceutical Company. 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 Fayazi Ashraf
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6649 2271 tums_edu@tums.ac.ir Tehran University of Medical Sciences scientific Ashraf Fayazi
No. 2, East Sahand Alley, Babataher Ave., Fatemi Ave., Tehran City
Tehran Iran (Islamic Republic of) 1414655541 +98 21 8896 3223 Fayaziyalda@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Parkinson's patients with major depression, no limit no limit Both Absence history of other major neurological disorders, such as epilepsy, head trauma, vascular disorders, stroke and dementia, and other major psychiatric disorders, including bipolar disorder, schizophrenia, substance abuse, and use of Antipsychotics in the last 6 months F32.8 G20 Other depressive episodes Parkinson's disease Treatment - Drugs Treatment - Drugs Intervention group 1: Depressed Parkinson's patients will be prescribed Bupropion tablets at an initial dose of 75 mg daily, and if there is no initial response after one month, the dose will be increased to 150 mg daily. The above drug is manufactured by Abidi Pharmaceutical Company Intervention group: Depressed patients with Parkinson's disease, Sertraline at a dose of 50 mg daily, and if there is no initial response after one month, an increase in dose to 100 mg daily will be prescribed. It is an drug from Abidi Pharmaceutical Company Severity of depression based on Beck's questionnaire. Timepoint: Measuring depression before intervention and then 1 and 3 month after intervention. Method of measurement: Beck's depression questionnaire. Tehran University of Medical Sciences Approved 2020-04-28 Ethics committee of Tehran University of Medical sciences No. 2 East Sahand Alley., Babataher Ave., Fatemi Ave., Tehran Tehran Iran (Islamic Republic of)