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COMPLETED Phase 2

A Study of Intermittent Doses of CERC-301 in MDD

NCT02459236 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 115 participants
Start Date 2015-06
Est. Completion 2016-12
Phase Phase 2

Sponsor

Avalo Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02459236

The ClinicalTrials.gov registry entry for NCT02459236 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avalo Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02459236 reports 13 study locations spanning 9 distinct geographic areas — top geographies include New York, Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02459236?

The interventions under investigation include: Placebo (DRUG), CERC-301 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02459236?

This trial is sponsored by Avalo Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial