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NCT01941043 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Major Depressive Disorder, sponsored by Avalo Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,357
- Enrollment target
- 20
- Study locations
NCT01941043: Completed Phase 2 study of Major Depressive Disorder, sponsored by Avalo Therapeutics.
NCT01941043 is a Phase 2 study of Major Depressive Disorder that has completed, run by Avalo Therapeutics. The registered enrollment target is 1,357 participants, above the 372-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (265% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01941043, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Avalo Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,357 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The overall between-treatment difference will be computed as the weighted average of the differences (drug vs. placebo)
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
| Field | Value |
|---|---|
| Enrollment Target | 1,357 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01941043 record still lists
NCT01941043 is an interventional study that assigns participants to a tested intervention. Its 1,357 participants enrollment target places it among the larger protocols in the corpus, above the 372-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (265% higher).
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.
NCT01941043 names 20 study sites across 9 states, led by California, Florida, New York.
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.
What interventions are being tested in trial NCT01941043?
The interventions under investigation include: Placebo (OTHER), CERC-301 (DRUG).
Who is sponsoring clinical trial NCT01941043?
This trial is sponsored by Avalo Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT01941043's enrollment target sits among peer trials
1,357 4th of 282 higher than 279 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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