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IRCT20221227056943N1 IRCT 2023-01-16 Zanjan University of Medical Sciences Dextromethorphan augmentation therapy for obsessive compulsive disorder Dextromethorphan augmentation therapy for moderate-to-severe obsessive–compulsive disorder: randomized, double-blind,placebo-controlled trial 2023-01-20 anticipated 54 Complete https://irct.ir/trial/67918 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to assign patients to two intervention and control groups, before the start of the study, the statistician determines the treatment group of the patients in the order of entering the study by generating random data with a binomial distribution with a probability of 0.5, and the patients are divided into two groups in the order of entering the study. A and B are entered. In this way, the researcher has no involvement in allocating the type of treatment. The outcome assessor and the clinician will not be aware of the randomization procedure, Blinding description: In order to assign patients to two intervention and control groups, before the start of the study, the statistician determines the treatment group of the patients in the order of entering the study by generating random data with a binomial distribution with a probability of 0.5, and the patients are divided into two groups in the order of entering the study. A and B are entered. According to the number of patients studied, dextromethorphan and placebo drugs, which are completely similar in terms of shape and size, are placed in similar boxes and the boxes are coded. Codes related to the drug and the placebo will be done by someone other than the researcher and clinician, and the patient, clinical caregiver, researcher, data collector, and data analyst will not know about it. will be given to patients. 4 obsessive compulsive disorder. Intervention 1: Intervention group: one tablet of dextromethorphan with a dose of 15 mg BID daily are given orally along with the previously used SSRI drug for 90 days from Dana Pharmaceutical Company. Intervention 2: Control group:One pill is given orally BID daily along with the previously used SSRI drug for 90 days. Yes - There is a plan to make this available What will be shared: Data may be published after de-identifying individuals. When: When publishing the results To whom: Researchers working in academic and scientific institutions Conditions: For scientific research Where to obtain: Library of Zanjan University of Medical Sciences How to obtain: Refer to the university library Comments:
public Romina Bagheri
Dr. Behshti Hospital,Arg Sq,Besat street,North Sadi
Zanjan Iran (Islamic Republic of) 4513615788 +98 28 3336 8142 Romina.bagheri.s@gmail.com Zanjan University of Medical Sciences scientific Romina Bagheri
Dr. Behshti Hospital,Arg Sq,Besat street,North Sadi
Zanjan Iran (Islamic Republic of) 4513615788 +98 28 3336 8142 Romina.bagheri.s@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with obsessive-compulsive disorder with moderate to high severity (YBOCS>16) Patients who have not responded to 12 weeks of obsessive-compulsive disorder treatment with an adequate dose of an SSRI People over 18 years old People who have filled out informed consent 18 years no limit Both Comorbidity with other psychiatric disorders except major depressive disorder, including psychotic disorders, substance dependence disorders Pregnancy Severe kidney and liver disease Unstable medical condition F42 Obsessive-compulsive disorder Treatment - Drugs Treatment - Drugs Intervention group: one tablet of dextromethorphan with a dose of 15 mg BID daily are given orally along with the previously used SSRI drug for 90 days from Dana Pharmaceutical Company. Control group:One pill is given orally BID daily along with the previously used SSRI drug for 90 days. Severity of Obsessive Compulsive Disorder based on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Timepoint: Yale-Brown obsessive compulsive scale (Y-BOCS) was measured at the beginning of the study and 30 and 90 days after the start of treatment. Method of measurement: Yale-Brown obsessive compulsive scale (Y-BOCS) Questionnaire. Zanjan University of Medical Sciences Approved 2022-11-22 Ethics committee of Zanjan University of Medical Sciences Dr. Behshti Hospital,Arg Sq,Besat street,North Sadi Zanjan Zanjan Iran (Islamic Republic of)