Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY2940094 40 mg administered orally as 1 capsule QD for 8 weeks. |
Drug: LY2940094
Administered orally
|
| Placebo Comparator: Placebo Administered orally as 1 capsule QD for 8 weeks. |
Drug: Placebo
Administered orally
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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. | North Miami | Florida | United States | 33161 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
Sponsors and Collaborators
- BlackThorn Therapeutics, Inc.
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14791
- I5J-MC-NOAC