RBR-6kmdtgb招募中2 期
Phase II, randomized, double-blind, crossover, placebo-controlled clinical trial to evaluate the efficacy and safety of Esketamine as an adjunct to standard care in patients with Obsessive-Compulsive Disorder
Hospital Universitário Professor Edgard Santos0 个研究点开始时间: 2022年10月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 65Y（—）
入选标准
- •Female or male subjects, 18 to 65 years of age; Each participant must have a sufficient level of understanding to understand all procedures and the informed consent form; Participants must complete for Obsessive-Compulsive Disorder in accordance with the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, for at least one year, as assessed by a structured diagnostic interview, The Mini International Neuropsychiatric Interview, version 7.0.2, with a Yale-Brown Obsessive-Compulsive Scale score of at least 16 points ;Treatment resistance defined as at least one prior attempt at an adequate dose and duration of a serotonin reuptake inhibitor or clomipramine and/or cognitive behavioral therapy with exposure and response prevention or having refused these treatments for individual reasons;Individuals should not have changes in the dosage of selective serotonin reuptake inhibitors or clomipramine by pe least two months before enrollment in the study
排除标准
- •Patients with severe depression defined by a Montgomery-Asberg Depression Rating Scale score greater than or equal to 34; Patients with imminent risk of suicide defined by a score greater than or equal to 4 on item 10 (suicidal thoughts) of the Montgomery-Asberg Depression Rating Scale; Use of other glutamate modulating agents; Current or past diagnosis of any psychotic disorder as defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders; Patients with a history of bipolar disorder as defined in the DSM-5; Individuals with a history of substance use disorder (except nicotine or caffeine) within the last 3 months according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders; Participants who are pregnant or breastfeeding; Serious and unstable medical illnesses; History of seizures without a clear and resolved etiology; Treatment with a monoamine oxidase inhibitor within 4 weeks prior to the study; Treatment with any other concomitant medication that may interfere with the evaluation of the results and/or safety of the participant; Presence of any medical disease that may alter the morphology and/or physiology of the brain; Investigators or their immediate family members; Patients who have started cognitive behavioral therapy with exposure and response prevention in the last 8 weeks prior to study enrollment; Patients who, after randomization, need to change the standard treatment by withdrawing or adding new drugs to their treatment regimen for Obsessive Compulsive Disorder should be excluded from the study to minimize potential biases caused by differences between groups
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