A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physical Symptoms - HMGR

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 520

Inclusion Criteria

[1] Meet criteria for MDD as defined by DSM-IV-TR and confirmed by the Mini International Neuropsychiatric Interview (MINI).
[2] Male or female outpatients = 18 years old.
[3] Have a MADRS total score = 20.
[4] At least 1 previous episode of depression in medical history.
[5] Have a painful physical symptoms with a score = 3 on the BPI-SF average pain question.
[6] Have Clinical Global Impression of Severity (CGI-S) score = 4.
[7] Provided written informed consent prior to any study procedure in accordance with Good Clinical Practice (GCP) and local regulatory requirements.
[8] Have a level of understanding sufficient to provide informed consent, complete protocol required self-rated assessments, and communicate intelligibly with the investigators, study coordinator, and site personnel.
[9] Are judged by the investigator to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol, and able to swallow all required medication without opening or crushing.
[10] Agree to not participate in any other research trial or study while enrolled in this study.

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

[1] Are investigator site personnel directly affiliated with this study and/or their immediate families.
[2] Are Lilly employees.
[3] Are 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 (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[4] Have previously completed or withdrawn from this study or any other study investigating duloxetine. (Note: Subjects who have been previously screened for a duloxetine study other than this study and who never received study drug will be eligible for this study if they meet all current entry criteria and none of the exclusion criteria).
[5] Are women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) who are not using a medically accepted means of contraception when engaging in sexual intercourse during the study and 1 month following the last dose of study drug. Note: Women who are pregnant or breastfeeding may not participate in the study.
[6] Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD, including, but not limited to, any anxiety disorder, dysthymia, or eating disorders as determined by subject history or by diagnosis using specific modules of the MINI.
[7] Have a history of alcohol abuse or dependence within 1 year immediately prior to screening.
[8] Have any prior history of bipolar disorder, psychosis, or schizophrenia.
[9] Have an Axis II disorder that, in the judgment of the investigator, would interfere with study compliance.
[10] Have a lack of response of any (lifetime of subject) episode of major depression to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the subject meets criteria for treatment-resistant depression.
[11] Have previously received treatment of MDD or GAD with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine.
[12] Diagnosis with acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C).
[13] Have uncontrolled narrow-angle glaucoma.
[14] Have a positive urine drug screen for any substance of abuse.
[15] Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study, in the opinion of the investigator.
[16] Have a history of substance abuse or dependence within 1 year immediately prior to screening (drug categories defined in the DSM-IV-TR), excluding nicotine and caffeine.
[17] Have a history of serious suicide attempt or subject judged clinically to be at serious suicidal risk in the opinion of the investigator.
[18] Require continuous use of analgesics (>step 2 WHO definition) because of chronic pain (>6 months).
[19] Have pain of a known origin.
[20] Meets criteria for fibromyalgia as defined by the American College of Rheumatology which includes the presence of chronic widespread pain and tenderness in all 4 body quadrants (above and below waist, and on the left and right sides of the body) for = 3 months and at least 11 of 18 tender point sites (Wolfe et al. 1990).
[21] Experience =1 migraine headache per

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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