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)
- Conditions
- Depressed patients (according to DSM-IV criteria) experiencing painful physical symptoms
- Registration Number
- EUCTR2004-003742-18-CZ
- Lead Sponsor
- Boehringer Ingelheim France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 310
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of Duloxetine 60mg once daily versus placebo over an 8-week treatment period, on somatic complaints of pain, as measured by the Brief Pain Inventory Short Form (BPI-SF) average pain question, in subjects meeting criteria for Major Depressive Disorder (as defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition);Secondary Objective: • Montgomery-Asberg Depression Rating Scale (MADRS) total score<br>• Time to sustained clinical response for Painful Physical Symptoms<br>• Time to sustained clinical response for overall depression symptoms<br>• Patient rated SCL-90R scale<br>• Patient rated PGI-improvement scale<br>• Physician rated CGI-severity scale<br>• Physician rated CGI-improvement scale<br>• Severity and interference scores of the BPI-SF<br>• Safety parameters;Primary end point(s): Change in BPI-SF average pain question score from baseline over the 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method