NCT02232555已完成3 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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 327
- 主要终点
- Change of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score
研究概览
简要总结
The purpose of this study was to investigate the efficacy of duloxetine versus placebo on pain in outpatients with major depressive disorder (MDD): change in Brief Pain Inventory Short Form (BPI-SF) 24-hour average pain score from baseline over the 8 weeks of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients who meet the criteria for MDD according to the Diagnostic and Statistic Manual of mental disorders, 4th edition (DSM-IV) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI)
- •Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20 at screening and baseline (Visits 1 and 2)
- •Patients must have had at least one previous episode of depression in their medical history
- •Painful physical symptoms (PPS) with a score ≥ 3 on the BPI-SF scale for average pain at screening and baseline
- •Patient aged 18 years or older at the screening visit
- •CGI-Severity score ≥ 4 at Visits 1 and 2
- •Patients willing and able to comply with the scheduled visits, tests and procedures required by the protocol
- •Written informed consent obtained at the screening visit, in accordance with Good clinical practice (GCP) and local regulatory requirements, prior to any study procedure
排除标准
- •Neuro-psychiatric exclusions
- •Lack of response of the current episode to 2 or more adequate courses of antidepressant therapy given at a clinically appropriate dose and for a sufficient length of time in the judgement of the investigator
- •Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, generalized anxiety disorder, and social phobia). Note: Specific phobias (i.e. agoraphobia, arachnophobia, etc.) will be allowed
- •Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
- •Presence of an Axis II disorder which, in the judgement of the investigator, would interfere with compliance with the study protocol
- •History of serious suicide attempt or patient judged to be at serious suicidal risk in the opinion of the investigator and / or score > 2 for question 10 (suicide) of the MADRS
- •History of drug dependence, including alcohol or benzodiazepines, according to DSM-IV, in the previous year
- •Positive urine screen for drug abuse (cannabis, benzodiazepines, barbiturates, opiates, cocaine, amphetamines)
- •Other medical exclusions
- •Patients requiring continuous treatment with 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 for epilepsy or seizures
- •Patients with a known diagnosis of raised intraocular pressure or at risk of acute narrow-angle glaucoma
- •Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency
- •Patients with severely impaired renal function, defined by a creatinine clearance < 30 mL/min (creatinine clearance was calculated by the central laboratory from the screening safety laboratory test
- •Acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis
- •Abnormal initial ECG findings according to investigator's judgement
- •Serious medical illness or clinically significant laboratory abnormalities which, in the judgement of the investigator, are likely to require medication/ intervention or hospitalization during the course of the study
- •Women of childbearing potential not using a medically accepted means of contraception when engaging in sexual intercourse (e.g. intrauterine device, oral contraceptive, contraceptive patch, implant, or barrier devices)
- •Women who are pregnant or breast-feeding
- •Pharmacological and other exclusions
- •Participation in another clinical trial within 30 days prior to screening (Visit 1)
- •Patients who have previously completed or withdrawn from this or any other study investigating duloxetine or have previously been treated with duloxetine
- •Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or potential need to use a MAOI within 5 days after discontinuation of study drug
- •Treatment with fluoxetine within 28 days prior to Visit 2
- •Treatment with any of excluded medications (listed in Protocol) within 7 days prior to Visit 2
- •(excepted MAOI within 14 days and fluoxetine within 28 days)
- •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 screening
- •Initiation or discontinuation of depression-oriented psychotherapeutic treatment (e.g. behavioural therapy, psychoanalytic therapy, cognitive therapy etc.) within 6 weeks prior to screening visit or planned use of such treatment at any time during the study
研究组 & 干预措施
Duloxetine
Experimental
干预措施: Duloxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score
时间窗: Up to 8 weeks after drug administration
次要结局
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score(Up to 8 weeks after drug administration)
- Clinical Global Impressions (CGIs) by investigator rated on CGI-improvement scale(Up to 8 weeks after drug administration)
- Number of patients with adverse events(Up to 8 weeks after drug administration)
- Number of patients withdrawing due to adverse event(Up to 8 weeks after drug administration)
- Patients Global Impression (PGI) rated on PGI-improvement scale(Up to 8 weeks after drug administration)
- Time to sustained clinical response for Painful Physical Symptoms (PPS) according BPI-SF score(Up to 8 weeks after drug administration)
- Change of patient symptoms rated on Symptom Checklist 90 Revised (SCL-90-R) scale(Up to 8 weeks after drug administration)
- Number of patients with clinical significant findings in laboratory values(Up to 8 weeks after drug administration)
- Time to sustained clinical response for overall depression symptoms(Up to 8 weeks after drug administration)
- Number of patients with clinical significant findings in vital signs(Up to 8 weeks after drug administration)
- Number of patients with clinical significant findings in weight(Up to 8 weeks after drug administration)
- Clinical Global Impressions (CGIs) by investigator rated on CGI-severity score(Up to 8 weeks after drug administration)
研究者
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