RCT of Duloxetine & Pregabalin for the treatment of Gulf War Illness in Veterans

度洛西汀的 RCT

• 批准号: 8970691
• 负责人: Dena Davidson
• 金额: --
• 依托单位: OLIN TEAGUE VETERANS CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2018-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8970691
• 关键词: Adrenal Glands; Adverse effects; Biogenic Amines; Brain; Calcium Channel; Cerebrospinal Fluid; Chronic; Classification Scheme; Combined Modality Therapy; Complex; Data; Development; Dose; Double-Blind Method; FDA approved; Fatigue; Fibromyalgia; Genes; Genetic; Gulf War; Headache; Health; Home environment; Hypothalamic structure; Immune response; Kansas; Ligands; Measures; Mediator of activation protein; Memory; Mono-S; Moods; Nerve Growth Factors; Neurotransmitters; Norepinephrine; Outcome; Pain; Pain Attribute; Pain management; Participant; Pharmaceutical Preparations; Phase; Physical Function; Pituitary Gland; Placebos; Process; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Regulation; Research; Safety; Serotonin; Sleep; Sleep disturbances; Statistical Data Interpretation; Structure; Substance P; Symptoms; Testing; Texas; Therapeutic; Veterans; active method; arm; associated symptom; central pain; chronic widespread pain; clinical practice; clinically relevant; control trial; dosage; duloxetine; effective therapy; experience; gastrointestinal; impression; improved; inhibitor/antagonist; meetings; open label; pregabalin; response; reuptake; symptomatic improvement; treatment group

DESCRIPTION (provided by applicant): The proposed randomized controlled clinical trial is a resubmission to the CSR&D RFA on new treatments for Gulf War illnesses. In a randomized, double-blind, controlled trial, 180 Veterans who meet defining criteria for GWI and whose symptom profile includes chronic widespread pain and fatigue will be treated for 18 weeks with one of the following combinations; Group 1) AM Duloxetine + PM placebo; Group 2) AM placebo and PM Pregabalin; or Group 3) AM placebo + PM placebo. PRIMARY AIM 1: To evaluate the efficacy of a Duloxetine and Pregabalin for the treatment of pain and safety and tolerability of the medications in Veterans with GWI. It is anticipated that monotherapy with Duloxetine or Pregabalin will result in a greater number of GWI participants achieving a clinically relevant reduction in pain compared to PBO alone. SECONDARY AIM 2: To evaluate the efficacy of a Duloxetine and Pregabalin for the treatment of sleep, fatigue, and mood in Veterans with GWI. It is anticipated that the active treatments in Group 1 & 2 will result in numerically greater improvement in these symptoms compared to Group 3. EXPLORATORY GENETIC AIM: To obtain pilot data on genes associated with medication response and to begin development of potential classification schemes that could guide choice of therapy.

描述(由申请人提供)： 拟议的随机对照临床试验是向CSR&D RFA提交的海湾战争疾病新疗法的重新提交。在一项随机、双盲、对照试验中，180名符合GWI定义标准且症状包括慢性广泛性疼痛和疲劳的退伍军人将接受以下组合之一为期18周的治疗：1)AM度洛西汀+PM安慰剂；2)AM安慰剂+PM普瑞巴林；或3)AM安慰剂+PM安慰剂。主要目的1：评价度洛西汀联合普瑞巴林治疗GWI退伍军人疼痛的疗效及安全性和耐受性。预计单用度洛西汀或普瑞巴林治疗将导致更大的 与单纯PBO相比，GWI参与者实现临床相关疼痛减轻的人数。次要目的2：评价度洛西汀和普瑞巴林治疗GWI退伍军人睡眠、疲劳和情绪的疗效。预计第1组和第2组的积极治疗将使这些症状在数字上比第3组有更大的改善。探索性遗传学目的：获得与药物反应相关的基因的先导数据，并开始开发可能指导治疗选择的分类方案。