EUCTR2004-003742-18-SK进行中（未招募）1 期
A ten-week, randomized, double-blind study evaluating the efficacy of Duloxetine 60 mg once daily versus placebo in outpatients with major depressive disorder and pain (EU-Pain enriched study)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Outpatients, aged 18 years or older at screening visit, who meet criteria for major depressive disorder, according to the DSM-IV criteria and confirmed by MINI
- •MADRS total score = or more than 20 at screening and baseline visits (V1 & V2)
- •Painful Physical Symptoms with a score = or more than 3 on the BPI-SF scale for average pain at V1 & V2
- •CGI-Severity score = or more than 4 at V1 & V2
- •Written informed consent at V1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Lack of response of the current episode to two or more adequate courses of antidepressant therapy
- •Any anxiety disorder as a primary diagnosis < 6 months
- •Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
- •Any Axis II disorders
- •History of serious suicide attempt or current serious suicidal risk and / or score > 2 on question 10 (suicide) of the MADRS
- •History of drug dependence, including alcohol or benzodiazepines < 1 year
- •Patients requiring continuously analgesics (> step 2 WHO definition) because of chronic pain (> 6 months)
- •Patients with organic pain syndromes
- •Epilepsy or history of seizure disorder or of a treatment with anticonvulsant medication
- •Known diagnosis of raised intraocular pressure or risk of acute narrow-angle glaucoma
- •Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency
- •Severely impaired renal function (creatinine clearance <30 mL/min)
- •Acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis
- •Women who are pregnant or breast-feeding or of childbearing potential not using medically accepted means of contraception
- •Participation in another clinical trial < 30 days prior to V1
- •Previous use of Duloxetine (including study investigating Duloxetine)
- •Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to V2 or potential need to use a MAOI within 5 days after discontinuation of study drug
- •Treatment with fluoxetine within 28 days prior to V2
- •Frequent and/or severe allergic reactions with multiple medications. Known hypersensitivity to Duloxetine or any of the inactive ingredients
- •Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one year prior to V1
- •Initiation or discontinuation of depression-oriented psychotherapeutic treatment within 6 weeks prior to V1 or planned use of such treatment at any time during the study
研究者
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