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

Major Depressive Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724112
• Other study ID #: 14791
• Secondary ID: I5J-MC-NOAC
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2012
• Last updated: February 1, 2017
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: BlackThorn Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• LY2940094
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
United States	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.	Albuquerque	New Mexico
United States	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	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.	Clinton	Utah
United States	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.	New York	New York
United States	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	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.	Oakland Park	Florida
United States	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.	Portland	Oregon
United States	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.	Prairie Village	Kansas
United States	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.	Staten Island	New York
United States	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.	University Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BlackThorn Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score		Baseline, Week 8
Secondary	Proportion of Participants Responding to Treatment		Baseline through Week 8
Secondary	Proportion of Participants who Achieved Remission		Week 8
Secondary	Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score		Baseline,Week 8
Secondary	Clinical Global Impression - Improvement (CGI-I) Score at Week 8		Week 8
Secondary	Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score		Baseline, Week 8
Secondary	Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score		Baseline, Week 4
Secondary	Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score		Baseline, Week 8
Secondary	Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC)		Baseline through 8 Weeks of Treatment