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
Public ClinicalTrials.gov record NCT01941043. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01941043
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,357 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2013 (Type not available)
- Primary completion
- Sep 2014 (Actual)
- Completion
- Oct 2014 (Actual)
- Last update posted
- Dec 21, 2017
2013 – 2014
United States locations
- U.S. sites
- 24
- U.S. states
- 13
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Arizona TMS Therapy Center | Phoenix | Arizona | 85032 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Collaborative NeuroScience Network, Inc. | Garden Grove | California | 92845 | — |
| Behavioral Research Specialists | Glendale | California | 91206 | — |
| Synergy Clinical Research Center | National City | California | 91950 | — |
| Pacific Clinical Trials, LLC | Oakland | California | 94612 | — |
| Southern CA Psychiatrists | Oceanside | California | 92056 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | — |
| Clinical Neuroscience Solutions | Jacksonville | Florida | 32256 | — |
| Scientific Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Clinical Neuroscience Solutions | Orlando | Florida | 32806 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | — |
| Chicago Psychiatry Associates | Chicago | Illinois | 60602 | — |
| Sheppard Pratt Health System | Baltimore | Maryland | 21285 | — |
| PCRC | O'Fallon | Missouri | 63368 | — |
| Bioscience Research | Mount Kisco | New York | 10549 | — |
| The Medical Research Network | New York | New York | 10128 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01941043, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2017 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01941043 live on ClinicalTrials.gov.