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IRCT20151103024853N5 IRCT 2020-11-04 Deputy of research and technology developement Riluzol effect on treatment of drug resistant obsessive obsessive compulsive disorder Evaluation of Riluzol effect as adjunctive therapy in patients with standard treatment-resistant obsessive-compulsive disorder 2020-02-20 anticipated 32 Complete https://irct.ir/trial/43571 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with 5 blocks will be performed for randomization of the study. The drug and placebo, which are made in exactly the same way, will be placed by the pharmacist unrelated to the research in equal packages of dark medicine with equal number, on the envelope with a label containing the information of the research center, how to use the medicine, patient number, and letters A or B will be placed for the drug group or placebo and the number will be registered in random order. The randomization tool will be statistical software that will be performed by the statistical analyzer of the study. When randomization is performed, each patient receives a code that will be recognized during the study. This code will be from 1 to 32 due to the small number of participants. The process of hiding and grouping patients and the type of medication they receive will not be disclosed to researchers, Blinding description: Both the drug and the placebo are indistinguishable from the patients and the relevant medical staff because they are exactly the same size, shape and color. The psychiatrist, the researcher recording the patient's condition and the delivery of the drug, and the patient are not aware that the drug received is the main drug or placebo. N/A Obsessive-compulsive disorder. Intervention 1: Intervention group: Intervention group: Intervention group drug Riluzole 50 mg tablets once a day for 12 weeks. Intervention 2: Control group: Placebo group 1 tablet daily for 12 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 I have not made a final decision yet.
public Mohammad hosein Shiveh
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8379 mohammad.shiveh@gmail.com Ahvaz University of Medical Sciences scientific Leila Kouti
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8379 lkouti.pharmacotherapy@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with known obsessive compulsive disorder by DSM-V criteria. Not to use alcohol chronic. The patient had no serious risk factor for respiratory apnea and pulmonary fibrosis and not be affected. Between 18 to 65 years old The individual should be treated with a maximum dose of SSRI for at least 6 months and scored 20 or higher on the Y-BOCS criterion. The patient's liver transaminase should not be more than 5 times higher than normal. no limit 65 years Both Pregnancy and nursing; Patients with a history of memantine use. Patients who do not sign the ethical consent form or refuse to continue to participate in the study. F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Intervention group: Intervention group: Intervention group drug Riluzole 50 mg tablets once a day for 12 weeks Control group: Placebo group 1 tablet daily for 12 weeks Patient's score in Y-BOCS test. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: the list of Riluzole adverse effects. Deputy of research and technology developement Approved 2020-02-02 Ahvaz Jundishapur University of Medical Sciences Golestan Esfand St. Jundishapur University of Medical Sciences School of Pharmacy Ahvaz Khouzestan Iran (Islamic Republic of)