study to evaluate the efficacy of duloxetine in outpatients with major depressive disorder and pain

Conditions: Depressive Disorder, Major

Summary: 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


Eligibility criteria:
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