A Comparison of Tolerability and Efficacy of Different Doses of Duloxetine for the Treatment of Major Depressive Disorder

A Comparison of Duloxetine Dosing Strategies in The Treatment of Patients With Major Depression

The purpose of this study is to compare the tolerability and efficacy of different doses of duloxetine in patients with major depressive disorder.

Inclusion Criteria:

• Outpatients at least 18 years of age (male and/or female) who meet criteria for major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual for Mental Disorders Fourth Edition Text Revision (DSM-IV-TR). Patients may have comorbid Anxiety Disorders, except for Obsessive Compulsive Disorder
• Tests negative for pregnancy at the time of enrollment based on a serum pregnancy test and agrees to use a reliable method of birth control (for example, use of oral contraceptives or Norplant a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug.
• Hamilton Depression Rating 17 Item Scale (HAMD-17) greater than 15 at Visits 1 and 2.

Exclusion Criteria:

• Have any current Axis I disorder other than major depressive disorder (MDD), dysthymia, or any anxiety disorder; however, obsessive-compulsive disorder is excluded.
• Have any previous or current diagnosis of bipolar disorder, obsessive-compulsive disorder, schizophrenia, or other psychotic disorders.
• Lack of response of the current episode of major depression to two or more adequate courses of antidepressant therapy at clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
• DSM-IV-TR-defined history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine.
• Patients judged to be at serious suicidal risk in the opinion of the investigator.