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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: LY2940094

• Registration Number: NCT01724112
• Lead Sponsor: BlackThorn Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-31
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Disposition First Submitted: 2014-04-14
• Disposition First Submitted QC: 2014-04-14
• Disposition First Posted: 2014-05-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered orally as 1 capsule QD for 8 weeks.
LY2940094	LY2940094	40 mg administered orally as 1 capsule QD for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

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.; 🇺🇸 Bellevue, Washington, United States