A Study in Adult Patients With Major Depressive Disorder

A Randomized, Double-Blind Comparison of LY2216684 and Placebo and Long Term Treatment With LY2216684 in Adult Patients With Major Depressive Disorder

The purpose of this study is to assess whether LY2216684 is superior to placebo in the treatment of adult patients with major depressive disorder.

Inclusion Criteria:

• Adults age 18-65 years
• Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders-fourth edition-text revision (DSM-IV-TR) criteria without psychotic features
• Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
• Grid 17-item Hamilton Rating Scale for Depression (GRID-HAMD17) total score ≥18 at Visit 1 and Visit 2
• Clinical global impressions of severity (CGI-S) score ≥4 at Visit 1 and Visit 2

Exclusion Criteria:

• Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
• Have previously completed or withdrawn from this study or any other study investigating LY2216684
• Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
• Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of Visit 1
• Have an Axis II disorder that would interfere with protocol compliance
• Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia, or other psychotic disorder
• Have a history of substance abuse within the past 1 year
• Women who are pregnant or breast-feeding
• Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy, or in the judgment of the investigator, considered to have treatment-resistant depression
• Participants who are judged to be at serious suicidal risk
• Have a serious or unstable medical illness
• Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
• Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1
• Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
• Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year
• Have a history of any seizure disorder (other than febrile seizures)
• Require psychotropic medication other than sedative/hypnotic medication for sleep
• Have a thyroid stimulating hormone (TSH) level outside the established reference range.
• Are taking or have received treatment with any excluded medication within 7 days prior to Visit 2
• Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
• A positive urine drug screen for any substance of abuse at Visit 1
• Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment