Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, 8 weeks

Secondary Outcomes (12)

Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score
Baseline, 8 weeks
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Baseline, 8 weeks
Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)
Baseline, up to 8 weeks
Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)
Baseline, 8 weeks
Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
Baseline, 8 weeks
+7 more secondary outcomes

Other Outcomes (2)

Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure
Baseline, 8 weeks
Change From Baseline to 8 Weeks in Supine Pulse
Baseline, 8 weeks

Study Arms (2)

LY2216684

EXPERIMENTAL

Drug: LY2216684

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LY2216684DRUG

Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.

LY2216684

PlaceboDRUG

3 tablets PO QD for up to 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
Meet criteria for partial response to an adequate course of treatment defined by the investigator's opinion that participant had attained at least minimal improvement on their current Selective serotonin reuptake inhibitor (SSRI) treatment
Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal 16 to at both study entry and study enrollment
SSRI treatment for at least 6 weeks at a stable dose for at least 2 weeks prior to study enrollment
Stated participant preference for augmentation rather than switching antidepressant treatment

You may not qualify if:

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 study entry
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
Have an Axis II disorder which, in the judgment of the investigator, would interfere with compliance with the protocol
Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression
Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year
Women who are pregnant or breastfeeding
Participants who are judged to be at serious risk for harm to self or others
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 a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
Have a history of any seizure disorder (other than febrile seizures)
+8 more criteria

Contact the study team to confirm eligibility.