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NCT02459236 · ClinicalTrials.gov registry record · Phase 2
A Study of Intermittent Doses of CERC-301 in MDD
A Phase 2 study of Major Depressive Disorder, sponsored by Avalo Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
- 13
- Study locations
NCT02459236: Completed Phase 2 study of Major Depressive Disorder, sponsored by Avalo Therapeutics.
NCT02459236 is a Phase 2 study of Major Depressive Disorder that has completed, run by Avalo Therapeutics. The registered enrollment target is 115 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (69% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02459236, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Avalo Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
- 13
- Study locations
Study Summary
There is a significant unmet medical need for rapidly acting treatment of subjects with severe major depressive disorder (MDD) who have not adequately responded to antidepressant therapy. Alternative therapies require weeks to achieve full efficacy, may have significant side effects, and still fail in a high percentage of subjects. Rapid reduction of severe depression by pharmacological therapy is important to reduce the need for hospitalization and risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable, N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it provides rapid onset of antidepressant effects and an effect size similar to that seen with experimental intravenous NMDA modulators.
Primary Outcome
To evaluate the antidepressant effect of CERC-301 (12 or 20 mg) compared to placebo averaged between 2 and 4 days post-treatment with study drug assessed by the 6-item unidimensional subset (Bech-6) of the 17-item Hamilton Depression Rating Scale (HDRS-17)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CERC-301
Study Locations (13)
New York
- Bioscience Research LLC - Mount Kisco
- The Medical Research Network, LLC - New York
- Fingerlakes Clinical Research - Rochester
- Richmond Behavioral Associates - Staten Island
Illinois
- Chicago Research Center, Inc. - Chicago
- Alexian Brothers Center for Psychiatric Research - Hoffman Estates
California
- Pharmacology Research Institute (PRI) - Newport Beach
Georgia
- Institute for Advanced Medical Research - Alpharetta
Missouri
- Psychiatric Care and Research Center - O'Fallon
Oregon
- Summit Research Network (Oregon) Inc. - Portland
Pennsylvania
- Lehigh Center for Clinical Research - Allentown
Tennessee
- Research Strategies of Memphis, LLC - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT02459236 record still lists
NCT02459236 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02459236 lists 13 locations in 9 states (New York, Illinois, California).
Frequently Asked Questions
What is clinical trial NCT02459236 about?
NCT02459236 is a clinical study titled "A Study of Intermittent Doses of CERC-301 in MDD". There is a significant unmet medical need for rapidly acting treatment of subjects with severe major depressive disorder (MDD) who have not adequately responded to antidepressant therapy. Alternative therapies require weeks to achieve full efficacy, may have significant side effects, and still fail ...
What is the current status of trial NCT02459236?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2015-06. Estimated completion is 2016-12.
What conditions does trial NCT02459236 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT02459236?
The interventions under investigation include: Placebo (DRUG), CERC-301 (DRUG).
Who is sponsoring clinical trial NCT02459236?
This trial is sponsored by Avalo Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02459236 being conducted?
This trial has 13 study locations across California, Georgia, Illinois, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02459236's enrollment target sits among peer trials
115 124th of 282 higher than 159 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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