a study of duloxetine in major depressive disorder (mdd) and associated painful symptoms

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.


Eligibility criteria:
inclusion criteria: * meets criteria for major depressive disorder (mdd) as defined by diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) and confirmed by mini international neuropsychiatric interview (mini) * montgomery-asberg depression rating scale (madrs) total score of greater than or equal to 20 during the screening phase * at least 1 previous episode of depression * painful physical symptoms with a score greater than or equal to 3 on the brief pain inventory-short form (bpi-sf) average pain question during the screening phase * a clinical global impression of severity (cgi-s) score of greater than or equal to 4 during the screening phase * written informed consent exclusion criteria: * currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device * previously completed or withdrawn from this study or any other study investigating duloxetine * women of child-bearing potential who are not using a medically accepted means of contraception * any current (within the past 6 months) dsm-iv-tr primary axis i diagnosis other than mdd * history of alcohol abuse or dependence within 1 year immediately prior to being screened for the study * any prior history of bipolar disorder, psychosis, or schizophrenia * have an axis ii disorder that would interfere with study compliance * lack of a response of any (lifetime of subject) episode of major depression greater than or equal to 2 adequate courses of antidepressant therapy, defined as a clinically appropriate dose for a minimum of 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment-resistant depression * have previously received treatment of mdd or generalized anxiety disorder (gad) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine * diagnosis of acute liver injury or severe cirrhosis * uncontrolled narrow-angle glaucoma * positive urine drug screen for any substance of abuse. * a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or a clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention * a history of substance abuse or dependence within 1 year before being screened for the study * history of a serious suicide attempt or subject judged clinically to be at serious suicidal risk * require continuous use of opioid analgesics for 6 or more months because of chronic pain * pain of a known origin * meets criteria for fibromyalgia as defined by the american college of rheumatology * experiences greater than or equal to 1 migraine headache per week * have had electroconvulsive therapy (ect), transcranial magnetic stimulation (tms), or vagus nerve stimulation (vns) within 1 year prior to being screened for the study * initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study * investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study * are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization * treatment with a monoamine oxidase inhibitor (maoi) within 14 days prior to randomization or have the potential need to use an maoi during the study or within 5 days of discontinuing study drug * frequent and/or severe allergic reactions with multiple medications * abnormal thyroid stimulating hormone concentration * has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures