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IRCT20170123032145N5 IRCT 2020-07-14 Iran University of Medical Sciences Agomelatine for treatment of Obsessive-Compulsive Disorder OCD Agomelatine as Adjunctive Therapy in Obsessive Compulsive Disorder A Double-blind,Placebo-controlled,Randomized Trial 2020-09-22 anticipated 44 Complete https://irct.ir/trial/49601 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 researchers, other than interviewer and who assess patients in follow-up visits, to write number of each participants on box of additional drugs. Therefore, all of patients, interviewer and who evaluates patients in follow-up visits will be unaware if each number belongs to which groups. 2-3 Obsessive-compulsive disorder. Intervention 1: Intervention group: Sertraline(Tab) up to 200 mg/day plus Agomelatine (Tab) 25 mg daily for 12 weeks. Intervention 2: Control group: Sertraline(Tab) up to 200 mg/day plus placebo(Tab) daily for 12 weeks. Yes - There is a plan to make this available What will be shared: Data about main outcome of study will be published When: 2024 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 of request Comments:
public Dr Mohammadreza Shalbafan
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1665 shalbafa.mr@iums.ac.ir Iran University of Medical Sciences scientific Dr Mohammadreza Shalbafan
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1665 shalbafa.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 Achieve more than 21 for Yale-Brown Obsessive Compulsive Scale Age: 18-65 year old Sign consent form 18 years 60 years Both They should not be treated by any psychiatric intervention for last 6 weeks. If they show any other important mental condition or suicidal thought, neurological deficit, will 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 Agomelatine (Tab) 25 mg daily for 12 weeks Control group: Sertraline(Tab) up to 200 mg/day plus placebo(Tab) daily for 12 weeks Severity of obsessive-compulsive disorder. Timepoint: Weeks: 0, 4, 8 and 12. Method of measurement: Yale-Brown Obsessive Compulsive Scale(YBOCS). Iran University of Medical Sciences Approved 2020-04-16 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)