A Study in Adult Patients With Major Depressive Disorder

Lilly

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depressive Disorder, Major

Treatments: Drug: LY2216684; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00795821

11313

H9P-MC-LNBI (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 495 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating LY2216684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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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495 participants in 2 patient groups, including a placebo group

LY2216684

Experimental group

Description:

10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug. 1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of acute treatment phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).

Treatment:

Drug: LY2216684

Placebo

Placebo Comparator group

Description:

10-week Acute Treatment Phase: 3 tablets QD for 10 weeks 1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684 dose; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).

Treatment:

Drug: Placebo