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IRCT20201004048919N1 IRCT 2021-05-11 Shiraz University of Medical Sciences Mirtazapine Augmentation in Resistant Obsessive Compulsive Disorder مطالعه روان پزشکی شیراز Mirtazapine Augmentation in Resistant Obsessive Compulsive Disorder:a Double Blind Placebo Controlled Clinical Trial 2021-07-21 anticipated 60 Complete https://irct.ir/trial/51433 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Due to the high prevance of OCD disease ,its effect on the patients interpersonal and occupational relationships to prevent wasting patients time requires the use of augmentation therapy strategy to help patients recover faster, Randomization description: patients are randomly (Flip the coin) 30 people in the placebo group and 30 people in the control group. Mirtazapine and placebo packaged in unnamed packages with the same name,and patients do not know about the patients medication and the contents of the packages, Blinding description: The study is double-blind.In this way, The patient and the relevant psychologist are unaware of whether the person is in the control or case group to perform the test. 3 Obsessive -compulsive disorder. Intervention 1: Sertraline tablets at a dose of 100-300 mg per day (depending on patient tolerance) with 7.5 to 30 mg of mirtazapine daily for 12 weeks as an intervention group. Intervention 2: Sertraline tablets at a dose of 100-300 mg per day (depending on patient tolerance) with placebo for 12 weeks as a control group. Yes - There is a plan to make this available What will be shared: Information about the main outcome will be shared after the study. When: 6 months after the end of the study To whom: All researchers working in academic and scientific institutions and people working in industry Conditions: Use in the treatment of patients Use in research Where to obtain: Shiraz University of Medical Sciences (Vice Chancellor for Research) How to obtain: Send a request to the research assistant expert, review by the relevant expert. Comments: Our protocol and data can be published and after completing the study ,we can publish them 6 months later
public Haniyeh baniasadipour
Hospital Hafez, chamran street
Shiraz Iran (Islamic Republic of) 7194634786 +98 71 3647 9531 h.baniasadipour@yahoo.com Shiraz University of Medical Sciences scientific Arash Mowla
Hospital Hafez,Chamran street
Shiraz Iran (Islamic Republic of) 7194634786 +98 71 3647 9531 mowlaar@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) people who have been diagnosed with obsessive -compulsive disorder based on DSM5. People with a yale-brown obsessive compulsive scale above 15. Has an age range of 18 to 60 years. 18 years 60 years Both Pregnant women and breastfeeding People receivinig psychotherapy. having major physical illnesse: liver problems (they have high liver enzymes),kidney problems(BUN ,CR are high), thyroid problem, trouble breathing. They have other psychiatric problems: According to the DSM5 criteria, they have psychotic disorder, anxiety disorder, dementia, mood disorder, and mental retardation. use drugs or alcohol F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Sertraline tablets at a dose of 100-300 mg per day (depending on patient tolerance) with 7.5 to 30 mg of mirtazapine daily for 12 weeks as an intervention group Sertraline tablets at a dose of 100-300 mg per day (depending on patient tolerance) with placebo for 12 weeks as a control group The severity of the symptoms of obsessive -compulsive disorder. Timepoint: The beginning of the study and 2-4-6-8-12 weeks after the start of treatment. Method of measurement: Based on the questionnaire Y-BOCS. Shiraz University of Medical Sciences Approved 2020-10-03 Ethics committee of Shiraz University of Medical Sciences Alavi dormitory,no. 2 ,Mollasadra street,namazi squ,shiraz Shiraz Fars Iran (Islamic Republic of)