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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01724112

Enrollment

136

Registered

2012-11-09

Start date

2012-11-30

Completion date

2014-03-31

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief 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.

Interventions

DRUGLY2940094

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
Proportion of Participants Responding to Treatment	Baseline through 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
Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score	Baseline, Week 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026