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COMPLETED Phase 2

A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment

NCT01941043 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG CERC-301

Study Locations (20)

California

  • ProScience Research Group — Culver City
  • Collaborative NeuroScience Network, Inc. — Garden Grove
  • Behavioral Research Specialists — Glendale
  • Synergy Clinical Research Center — National City
  • Pacific Clinical Trials, LLC — Oakland
  • Southern CA Psychiatrists — Oceanside
  • Artemis Institute for Clinical Research — San Diego

Florida

  • Clinical Neuroscience Solutions — Jacksonville
  • Scientific Clinical Research, Inc. — North Miami
  • Clinical Neuroscience Solutions — Orlando

New York

  • Bioscience Research — Mount Kisco
  • The Medical Research Network — New York
  • Finger Lakes Clinical Research — Rochester

Georgia

  • Atlanta Center for Medical Research — Atlanta
  • Northwest Behavioral Research Center — Marietta

Alabama

  • University of Alabama at Birmingham — Birmingham

Arizona

  • Arizona TMS Therapy Center — Phoenix

Illinois

  • Chicago Psychiatry Associates — Chicago

Maryland

  • Sheppard Pratt Health System — Baltimore

Trial Details

FieldValue
Enrollment Target 1,357 participants
Start Date 2013-11
Est. Completion 2014-10
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 NCT01941043

The ClinicalTrials.gov registry entry for NCT01941043 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 1,357 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: NCT01941043 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, New York. 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 NCT01941043 about?

NCT01941043 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment". 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)....

What is the current status of trial NCT01941043?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,357 participants. The study started on 2013-11. Estimated completion is 2014-10.

What conditions does trial NCT01941043 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 NCT01941043?

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

Who is sponsoring clinical trial NCT01941043?

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 NCT01941043 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. 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