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IRCT20170123032145N3 IRCT 2019-03-27 Iran University of Medical Sciences Granisetron for treatment of Obsessive-Compulsive Disorder OCD The Efficacy of Granisetron as Adjunctive Therapy in Obsessive Compulsive Disorder A Double-blind, Placebo-controlled, Randomized Trial 2019-04-06 anticipated 44 Complete https://irct.ir/trial/38329 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks, Blinding description: To do study with concealment, table of block will be used by one of researches, other than interviewer and who will assess patients in follow-up visits, to write number of each participants on box of additional drugs. Therefore, all of patients, interviewer and who will assess patients in follow-up visits will be unaware of each number belongs to which groups. N/A Obsessive-compulsive disorder. Intervention 1: Intervention group: Sertraline(Tab) up to 200 mg/day plus Granisetron(Tab) 1mg twice per day for 10 weeks. Intervention 2: Control group: Sertraline(Tab) up to 200 mg/day plus placebo(Tab) twice per day for 10 weeks. Yes - There is a plan to make this available What will be shared: Data about main outcome of study will be published When: 2021 To whom: Academic researchers Conditions: For scientific goals Where to obtain: shalbafan.mr@iums.ac.ir Dr Mohammadreza Shalbafan How to obtain: Sending an E-mail and reason for request Comments:
public Dr Mohammadreza Shalbafan
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1398913151 +98 21 4450 3395 Shalbafan.mr@iums.ac.ir Iran University of Medical Sciences scientific Dr Mohammadreza Shalbafan
Iran University of Medical Sciences, Shahid Hemmat Highway,
Tehran Iran (Islamic Republic of) 1449614535 +98 21 4450 3395 Shalbafan.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who meet DSM-5 criterion for OCD and they achieve more than 21 for Yale-Brown Obsessive Compulsive Scale are suitable for study. They should be 18-65 years old Sign consent form 18 years 65 years Both They should not be treated by any psychiatric interventions for 6 weeks ago. If they show any other mental important conditions or suicidal thoughts, neurological deficits, exclude from study. They will be evaluated for cardiac, liver, kidney, pregnancy, lactation and mental retardation before entrance and any mentioned conditions will cause exclusion from study. F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Intervention group: Sertraline(Tab) up to 200 mg/day plus Granisetron(Tab) 1mg twice per day for 10 weeks Control group: Sertraline(Tab) up to 200 mg/day plus placebo(Tab) twice per day for 10 weeks Severity of obsessive-compulsive disorder. Timepoint: Weeks: 0, 4, 8 and 10. Method of measurement: Yale-Brown Obsessive Compulsive Scale(YBOCS). Side effects. Timepoint: Weeks: 1, 4, 8 and 10. Method of measurement: Checklist. Iran University of Medical Sciences Approved 2019-03-14 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)