A Study in Adult Patients With Major Depressive Disorder

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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• Have previously completed or withdrawn from this study or any other study investigating LY2216684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