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IRCT2016020421745N4 IRCT 2016-04-20 Vice chancellor of research Shiraz University of Medical Sciences Effects of Escitalopram in treatment of patients with obsession Clinical trial of comparing the effects of Escitalopram with Setraline on the severity of signs and symptoms of patients with obsessive compulsive disorder 2016-04-03 anticipated 70 Complete https://irct.ir/trial/18974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The type of randomization in this study is blocking randomization. This study is a double blind study; The patients and the assistant that evaluates severity of signs and symptoms and primary outcome measures do not know about the type of the intervention that each patient had received. Just the psychiatrist knows about the name of the drug which is prescribed for each patient. 2-3 obsessive compulsive disorder. Intervention 1: Intervention group (group A) will receive Escitalopram for 6 weeks. Escitalopram tablets are 10mg tablets that are produced by Hakim pharmaceutical company. Making all tablets the same series.The initial dose for Escitalopram is 10mg per day and will be increased till patients clinically response or side effects appear. Maximum dose for Escitalopram is 20mg per day. Physical exam, clinical diagnosis and drug prescription will be done by psychiatrist, but evaluation of the signs and symptoms and side effects will be done by the assistant. Severity of the OCD signs and symptoms will be evaluated by Yale Brown Obsessive Compulsive Scale (Y-BOCS) at the beginning of the study and at the end of the 6th week of study. To evaluate the clinical response Clinical Global Impressions Improvement Scale (CGII) will be used at the end of the study, too. Y-BOCS is a validated questionnaire that is widely used in clinical practice and research to assess the severity and to follow the improvement of clinical features. Y-BOCS consists of 10 items and each item is scored from 0 to 4. The questionnaire includes how much time does the patient spend on obsession, the problems that they have in their life as a result of OCD, how much control does the patient have on the obsessional thoughts and etc. CGI is a quantitative questionnaire, that consists of 2 scales, one for severity and the other for improvement of the disorder. Each scale is scored ranging from 0 to 7. In this study just improvement scale will be used at the end of the study. This test is widely used in the clinic for different anxiety disorders. Intervention 2: Control group (group B) will receive Sertraline for 6 weeks. Sertraline tablets are 50mg tablets that are produced by Sobhandaroo pharmaceutical company. Making all tablets the same series.The initial dose for Sertraline is 50mg per day and will be increased till patients clinically response or side effects appear. Maximum dose for Sertraline is 200mg per day. Physical exam, clinical diagnosis and drug prescription will be done by psychiatrist, but evaluation of the signs and symptoms and side effects will be done by the assistant. Severity of the OCD signs and symptoms will be evaluate by Yale Brown Obsessive Compulsive Scale (Y-BOCS) at the beginning of the study and at the end of the 6th week of study. To evaluate the clinical response Clinical Global Impressions Improvement Scale (CGII) will be used at the end of the study, too. Y-BOCS is a validated questionnaire that is widely used in clinical practice and research to assess the severity and to follow the improvement of clinical features. Y-BOCS consists of 10 items and each item is scored from 0 to 4. The questionnaire includes how much time does the patient spend on obsession, the problems that they have in their life as a result of OCD, how much control does the patient have on the obsessional thoughts and etc. CGI is a quantitative questionnaire, that consists of 2 scales, one for severity and the other for improvement of the disorder. Each item is scored ranging from 0 to 7. In this study just improvement scale will be used at the end of the study. This test is widely used in the clinic for different anxiety disorders.
public Farzaneh Modaresi
Department of Psychiatry, Hafez Hospital, Chamran Avenue
Shiraz Iran (Islamic Republic of) +98 71 3627 9319 drfarzanehmodaresi84@yahoo.com Shiraz University of Medical Sciences scientific Arash mowlaa
Department of Psychiatry, Hafez Hospital, Chamran Avenue
Shiraz Iran (Islamic Republic of) +98 71 3627 9319 mowlaar@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Patients with obsessive compulsive disorder (OCD) that diagnosed with interview by psychiatrist according to DSM-IV TR; Yale-Brown-obsessive-compulsive scale equal or more than 18; Informed consent of patients. Exclusion criteria: Other psychiatric disorder diagnosis according to axis I and II; Major medical illness like hypertension, diabetes, cardiovascular disease, renal disease and gastrointestinal disease; Pregnancy and lactation; Substance or alcohol abuse; Any intolerable adverse side effects of treatment; Any SSRI usage in past 5 weeks; Patients younger than 18 years and older than 65 years old. 18 years 65 years Both F42 The essential feature is recurrent obsessional thoughts or compulsive acts. Obsessional thoughts are ideas, images, or impulses that enter the patient's mind again and again in a stereotyped form. They are almost invariably distressing and the patient oft Treatment - Drugs Treatment - Drugs Intervention group (group A) will receive Escitalopram for 6 weeks. Escitalopram tablets are 10mg tablets that are produced by Hakim pharmaceutical company. Making all tablets the same series.The initial dose for Escitalopram is 10mg per day and will be increased till patients clinically response or side effects appear. Maximum dose for Escitalopram is 20mg per day. Physical exam, clinical diagnosis and drug prescription will be done by psychiatrist, but evaluation of the signs and symptoms and side effects will be done by the assistant. Severity of the OCD signs and symptoms will be evaluated by Yale Brown Obsessive Compulsive Scale (Y-BOCS) at the beginning of the study and at the end of the 6th week of study. To evaluate the clinical response Clinical Global Impressions Improvement Scale (CGII) will be used at the end of the study, too. Y-BOCS is a validated questionnaire that is widely used in clinical practice and research to assess the severity and to follow the improvement of clinical features. Y-BOCS consists of 10 items and each item is scored from 0 to 4. The questionnaire includes how much time does the patient spend on obsession, the problems that they have in their life as a result of OCD, how much control does the patient have on the obsessional thoughts and etc. CGI is a quantitative questionnaire, that consists of 2 scales, one for severity and the other for improvement of the disorder. Each scale is scored ranging from 0 to 7. In this study just improvement scale will be used at the end of the study. This test is widely used in the clinic for different anxiety disorders. Control group (group B) will receive Sertraline for 6 weeks. Sertraline tablets are 50mg tablets that are produced by Sobhandaroo pharmaceutical company. Making all tablets the same series.The initial dose for Sertraline is 50mg per day and will be increased till patients clinically response or side effects appear. Maximum dose for Sertraline is 200mg per day. Physical exam, clinical diagnosis and drug prescription will be done by psychiatrist, but evaluation of the signs and symptoms and side effects will be done by the assistant. Severity of the OCD signs and symptoms will be evaluate by Yale Brown Obsessive Compulsive Scale (Y-BOCS) at the beginning of the study and at the end of the 6th week of study. To evaluate the clinical response Clinical Global Impressions Improvement Scale (CGII) will be used at the end of the study, too. Y-BOCS is a validated questionnaire that is widely used in clinical practice and research to assess the severity and to follow the improvement of clinical features. Y-BOCS consists of 10 items and each item is scored from 0 to 4. The questionnaire includes how much time does the patient spend on obsession, the problems that they have in their life as a result of OCD, how much control does the patient have on the obsessional thoughts and etc. CGI is a quantitative questionnaire, that consists of 2 scales, one for severity and the other for improvement of the disorder. Each item is scored ranging from 0 to 7. In this study just improvement scale will be used at the end of the study. This test is widely used in the clinic for different anxiety disorders. Severity of signs and symptoms of the patients with obcessive compulsive disorder. Timepoint: At the beginning of study and at the sixth week of study. Method of measurement: Y-BOCS At the beginning of study and at the sixth week of study and CGI-Improvement test at sixth week of study. Vice chancellor of research Shiraz University of Medical Sciences Approved 2016-01-30 Research Ethics Committee of Shiraz University of Medical Science Medical school, Zand avenue Shiraz Iran (Islamic Republic of)