Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01724112 |
Recruitment Status :
Completed
First Posted : November 9, 2012
Last Update Posted : February 3, 2017
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Condition or disease | Intervention/treatment | Phase |
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Major Depressive Disorder | Drug: LY2940094 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 136 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: LY2940094
40 mg administered orally as 1 capsule QD for 8 weeks.
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Drug: LY2940094
Administered orally |
Placebo Comparator: Placebo
Administered orally as 1 capsule QD for 8 weeks.
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Drug: Placebo
Administered orally |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724112
United States, Florida | |
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, 33161 | |
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, 33334 | |
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, United States, 34201 | |
United States, Kansas | |
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, 66206 | |
United States, New Mexico | |
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, 87109 | |
United States, New York | |
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, 10021 | |
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, 10312 | |
United States, Oregon | |
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, 97210 | |
United States, Utah | |
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, 84015 | |
United States, Washington | |
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, 98007 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | BlackThorn Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01724112 |
Other Study ID Numbers: |
14791 I5J-MC-NOAC ( Other Identifier: Eli Lilly and Company ) |
First Posted: | November 9, 2012 Key Record Dates |
Last Update Posted: | February 3, 2017 |
Last Verified: | February 2017 |
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |