Depressed patients (according to DSM-IV criteria) experiencing painful physical symptoms
Conditions
Interventions
Trade Name: Cymbalta / Xeristar
Product Name: Duloxetine (Cymbalta)
Product Code: LY248686
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: duloxetine
Concentration unit: mg milligram(s)
Conc
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • Lack of response of the current episode to two or more adequate courses of antidepressant therapy • Any anxiety disorder as a primary diagnosis 2 on question 10 (suicide) of the MADRS • History of drug dependence, including alcohol or benzodiazepines 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • Time to sustained clinical response for Painful Physical Symptoms • Time to sustained clinical response for overall depression symptoms • Patient rated SCL-90R scale • Patient rated PGI-improvement scale • Physician rated CGI-severity scale • Physician rated CGI-improvement scale • Severity and interference scores of the BPI-SF • Safety parameters;Primary end point(s): Change in BPI-SF "average pain" question score from baseline over the 8 weeks of treatment | — |
Countries
Czech Republic, Finland, Germany
Outcome results
None listed