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Lead
Duke University
This is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive Disorder (MDD).
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
ages 18-65
primary diagnosis of MDD based on Diagnostic Standard Manual(DSM-IV) criteria and assessed by the MINI International Neuropsychiatric Interview
Montgomery-Asberg Depression Rating Scale (MADRS)score of at least 20 on baseline
Minimum Clinical Global Impressions of Severity (CGS) severity score of 4
Ability to provide written consent form
A negative serum pregnancy test for women of childbearing potential
You may not be if
Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition
History of substance abuse or dependence within the last 6 months
Suicide risk or serious suicide attempt within the last year
Clinically significant medical condition or laboratory abnormality
Women of childbearing potential who are unwilling to practice an acceptable method of contraception
Subjects needing concurrent use of psychotropic medications
History of sensitivity to duloxetine
History of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks)
