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IRCT20190726044339N3 IRCT 2020-12-23 Shiraz University of Medical Sciences The effect of Agomalatin on resistant obsessive compulsive disorder patients The comparison of the effect of Agomalatin and Placebo on symptoms of obsession in resistant obsessive compulsive disorder patients 2020-11-21 anticipated 60 Complete https://irct.ir/trial/52170 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher will enroll participants based on convenience sampling method. NCSS software (Number Cruncher Statistical System) and block randomization method will be used for randomization in the study. In the block randomization method, participants will categorize into 6 blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB), each block containing 4 participants. In this study, "A" will assign to the drug group and "B" to the placebo group, for example: in the "ABAB" block, the first person enters the drug group, the second person enters the placebo group, the third person enters the drug group, and the fourth person enters the placebo group. Thus, all eligible participants will randomly be assigned to one of the study arms according to the randomization list, Blinding description: Physicians, patients, and drug deliverer will blind to the allocation of intervention. It should be noted that the drugs' containers is the same. Additionally, placebo pill is similar to agomelatin pill regarding the color and shape. 2-3 obsessive-compulsive disorder (OCD). Intervention 1: Intervention group: agomelatin 25 mg one tablet per night with 100 mg of sertraline daily for 12 weeks. Intervention 2: Control group: One placebo tablet every night with a daily intake of 100 mg of sertraline for twelve weeks. 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 Azadeh Nejati
Hafez street
Shiraz Iran (Islamic Republic of) 7654971466 +98 71 3228 9601 hamdi_88114@yahoo.com Shiraz University of Medical Sciences scientific Amir Bazrafshan
Hafez street
Shiraz Iran (Islamic Republic of) 71466 76549 +98 917 309 9835 Bazrafshana@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with resistant obsessive-compulsive disorder who have not taken any medication for 3 months before the start of the study Score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) above 15 no limit no limit Both Having other psychiatric disorder Pregnancy and lactation Having Hepatic disorder Receive concomitant psychotherapy F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Intervention group: agomelatin 25 mg one tablet per night with 100 mg of sertraline daily for 12 weeks Control group: One placebo tablet every night with a daily intake of 100 mg of sertraline for twelve weeks Obsession severity. Timepoint: At the beginning of the study and at the 12th week. Method of measurement: Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Shiraz University of Medical Sciences Approved 2020-04-16 Shiraz University of Medical Sciences Ibn Sina Hospital; Hafez street Shiraz Fars Iran (Islamic Republic of)