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)
Verified date | February 2017 |
Source | BlackThorn Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
BlackThorn Therapeutics, Inc. |
United States,
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 |
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