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IRCT20140926019295N3 IRCT 2022-09-13 Shiraz University of Medical Sciences Evaluation of risperidone efficacy versus placebo in treatment of obsessive compulsive disorder symptoms in bipolar patients Evaluation of risperidone efficacy versus placebo in treatment of obsessive compulsive disorder symptoms in bipolar patients 2022-08-23 anticipated 20 Complete https://irct.ir/trial/64050 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study will be permutation block method in such a way that A represents the person who receives the intervention and B represents the person who receives the control. This method considering blocks of four so that the total number of possible permutations of four is equal to 6, including: ABAB, BABA, AABB, BBAA and BAAB ABBA. Then, by using the table of random numbers and assigning a code from 0 to 9 to each of the permutations, the desired random list of 40 items that includes 10 blocks of 4 items (total number of samples = 40 x 10) is produced (using from the computer) and the order of assigning each of the methods to each of the samples participating in the study is determined, Blinding description: In this study, the patients and the evaluator who perform the Yale-Brown test to measure the severity of obsessive-compulsive symptoms are not aware of the grouping and the type of medication received (risperidone versus placebo). 3 اختلال وسواسی جبری-اختلال دوقطبی. Intervention 1: Intervention group: risperidone with initial dose 5mg for 12 weeks and at intervals of 4, 8, and 12 weeks, the level of obsessive symptoms will be evaluated using the Yale Brown questionnair. Intervention 2: Control group: In the control group, like the intervention group, they receive standard treatment including lithium and benzodiazepine, and they are also given a placebo drug. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information is provided
public Mahsa Ghavipisheh
Chamran Blv. Hafez hospital- psychiatry department
Shiraz Iran (Islamic Republic of) 7144734189 +98 71 3647 9319 mghavipisheh@gmail.com Shiraz University of Medical Sciences scientific Ali Sahraian
Department of Psychiatry- Hafez hospital
Shiraz Iran (Islamic Republic of) 7144734189 +98 71 3627 9319 sahraian@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) DSM-5 criteria for Bipolar disorder type 1 or 2 yale-brown score higher than 61 Coincidence of Bipolar disorder and obsessive-compulsive disorder 18 years no limit Both Acute phase of mania or depression Major medical conditions(cardiovascular-respiratory-renal-digestive) Pregnancy F42 Obsessive-compulsive disorder Treatment - Drugs Treatment - Drugs Intervention group: risperidone with initial dose 5mg for 12 weeks and at intervals of 4, 8, and 12 weeks, the level of obsessive symptoms will be evaluated using the Yale Brown questionnair Control group: In the control group, like the intervention group, they receive standard treatment including lithium and benzodiazepine, and they are also given a placebo drug. Obsessional symptoms. Timepoint: 4 and 8 weeks after receiving risperidone. Method of measurement: yale brown questionnaire. Shiraz University of Medical Sciences Approved 2022-05-10 Ethics committee of Shiraz University of Medical Sciences chamran Blvd. hafez hospital. psychiatry department shiraz Fars Iran (Islamic Republic of)