Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg) once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.

Official Title
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8-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of LY2940094 Administered Once Daily in Patients With Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: LY2940094
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of MDD without psychotic features as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Have clinically significant depressive symptoms defined by a GRID Hamilton Depression Rating Scale 17 (HAMD17) Total Score ≥20 at screening Body mass index (BMI) between 18 and 35 kilogram per square meter (kg/m²) Exclusion Criteria: Have a current or previous diagnosis of bipolar I or II disorder, MDD with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder Currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode Had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening Have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2940094<br>40 mg administered orally as 1 capsule QD for 8 weeks. | Drug: LY2940094<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Administered orally as 1 capsule QD for 8 weeks. | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score |  | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Responding to Treatment |  | Baseline through Week 8 | 
| Proportion of Participants who Achieved Remission |  | Week 8 | 
| Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score |  | Baseline,Week 8 | 
| Clinical Global Impression - Improvement (CGI-I) Score at Week 8 |  | Week 8 | 
| Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score |  | Baseline, Week 8 | 
| Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score |  | Baseline, Week 4 | 
| Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score |  | Baseline, Week 8 | 
| Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC) |  | Baseline through 8 Weeks of Treatment |