Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain

Inclusion Criteria: * 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 Exclusion Criteria: 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