The current study will evaluate the antidepressant effect of CERC-301 during 28 days of treatment in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that would benefit most from rapid onset, those with recent active suicidal ideation, but not a risk to themselves or others and are deemed appropriate for an out-patient study with careful safety surveillance. This will allow the study to focus on the antidepressant effects of CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a secondary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,357
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona TMS Therapy Center
Phoenix, Arizona, United States
ProScience Research Group
Culver City, California, United States
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States
Behavioral Research Specialists
Glendale, California, United States
Synergy Clinical Research Center
National City, California, United States
Pacific Clinical Trials, LLC
Oakland, California, United States
Southern CA Psychiatrists
Oceanside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, United States
...and 14 more locations
HDRS-17 after 7 days of dosing with study drug
The overall between-treatment difference will be computed as the weighted average of the differences (drug vs. placebo)
Time frame: Screening & Days 0, 4, 7, 11, 14, 21,28, & 35
HDRS-17 Averaged between 7 and 28 days of treatment with study drug
This will be analyzed using the mixed effects model for repeated measures. The between-group (drug vs. placebo) differences will be estimated by the least squares mean for the contrast in the main effect.
Time frame: Screening, Days 0, 4, 7, 11, 14, 21, 28, & 35
HDRS-17 after 28 days of dosing with study drug
This will be analyzed using the mixed effects model for repeated measures . The between-group difference will be estimates by the least squares mean difference at Day 28 as a simple contrast from the model.
Time frame: Screening, Days 0, 4, 7, 11, 14, 21, 28, 35
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