Overview

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

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BlackThorn Therapeutics, Inc.
Eli Lilly and Company
Criteria
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