A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

Inclusion Criteria:

• Clinical diagnosis of Major Depressive Disorder (MDD)
• Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control
• Are taking an SSRI approved for MDD treatment within the patient's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country
• Have a partial response to SSRI treatment
• Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment
• Reliable and able to keep all scheduled appointments

Exclusion Criteria:

• Presence of another primary psychiatric illness:

  • Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening
  • Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)
  • Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder
  • Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine.
  • Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
• Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, urinary hesitation or retention
• Use of excluded concomitant or psychotropic medication other than SSRI
• Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment
• Have treatment resistant depression
• Have a lifetime history of vagal nerve stimulation, transcranial magnetic stimulation, or psychosurgery
• Have received electroconvulsive therapy in the last year
• Enrollment in a clinical study for an investigational drug
• Serious or unstable medical condition
• History of seizure disorders
• Have initiated psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 12 weeks prior to enrollment or any time during the study. No change in intensity of psychotherapy within the last 6 weeks prior to enrollment or at any time during the study.
• Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others