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

BlackThorn Therapeutics, Inc.136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

136

Conditions

Major Depressive Disorder

Interventions

LY2940094DRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (10)

Outcomes

Primary Outcomes

Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score

Time frame: Baseline, Week 8

Secondary Outcomes

Proportion of Participants Responding to Treatment

Time frame: Baseline through Week 8

Proportion of Participants who Achieved Remission

Time frame: Week 8

Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score

Time frame: Baseline,Week 8

Clinical Global Impression - Improvement (CGI-I) Score at Week 8

Time frame: Week 8

Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score

Time frame: Baseline, Week 8

Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score

Time frame: Baseline, Week 4

Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score

Time frame: Baseline, Week 8

Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC)

Time frame: Baseline through 8 Weeks of Treatment

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

North Miami, Florida, United States

Oakland Park, Florida, United States

University Park, Florida, United States

Prairie Village, Kansas, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Staten Island, New York, United States

Portland, Oregon, United States

Clinton, Utah, United States

Bellevue, Washington, United States