A Study of Intermittent Doses of CERC-301 in MDD

September 25, 2017 updated by: Avalo Therapeutics, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study of Intermittent Doses of CERC-301 in the Treatment of Subjects With Severe Depression Despite Antidepressant Treatment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will evaluate the antidepressant effect of one or two administrations of two doses of CERC-301 (12 mg and 20 mg) in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with a selective serotonin- or serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute (PRI)
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Institute for Advanced Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Chicago Research Center, Inc.
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Psychiatric Care and Research Center
    • New York
      • Mount Kisco, New York, United States, 10549
        • Bioscience Research LLC
      • New York, New York, United States, 10128
        • The Medical Research Network, LLC
      • Rochester, New York, United States, 14618
        • Fingerlakes Clinical Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • Oregon
      • Portland, Oregon, United States, 97201
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center for Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Strategies of Memphis, LLC
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of MDD recurrent without psychotic features according to DSM-IV-TR criteria with diagnosis confirmed using the Structured Clinical Interview for DSM-IV Axis I Disorders Clinical Trials Version (SCID-CT).
  2. Lifetime history of ≥2 major depressive episodes, for which at least one required treatment with SSRI or SNRI antidepressants.
  3. History during the current major depressive episode of failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to ≤3 treatment courses of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration during the current episode, according to the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire.

Exclusion Criteria:

  1. Duration of current depression episode ≥2 years or diagnosis of Persistent Depressive Disorder (DSM-V) or Dysthymic Disorder (DSM-IV)
  2. Use of other NMDA-receptor modulators (e.g., dextromethorphan, ketamine, amantadine, memantine) within 30 days of screening and throughout the study.
  3. History of use of an NMDA-receptor modulator for the treatment of MDD.
  4. Use of bupropion, tricyclic antidepressants, antipsychotics, stimulants, or lithium within 8 weeks prior to screening
  5. Initiation of psychotherapy or a change in intensity of psychotherapy or other non-drug therapies (e.g., hypnosis, acupuncture) within 8 weeks prior to screening.
  6. Electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation during the current depressive episode.
  7. Excessive alcohol use, which is defined by the Centers for Disease Control as >1 drink per day for women and >2 drinks per day for men.
  8. Current diagnosis of a Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by DSM-IV/V), with the exception of nicotine dependence, at screening or within 6 months prior to screening.
  9. Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.).
  10. Current neurologic or neuropsychiatric disorder which could interfere with the ability to diagnose or assess MDD or which could cause or contribute to depressive symptomatology (e.g., Alzheimer's disease, Parkinson's diseases, chronic pain syndromes, including fibromyalgia, substance use disorder, post-partum depression).
  11. Lifetime history of the following disorders: Bipolar I, II, or Not Otherwise Specified (NOS) mood disorders, eating disorders , schizophrenia and other psychotic disorders, sleep disorders , significant cognitive disorders, dissociative disorders, impulse control disorders, and borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorders.
  12. Subjects with suicidal behavior within 6 months prior to screening as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) "Baseline/Screening" version.
  13. Elevated seated blood pressure at screening and prior to randomization
  14. Lifetime history of stroke or congestive heart failure, atrial fibrillation or coronary artery disease.
  15. Clinically significant current liver disease or liver enzyme (GGT, ALT, AST, total bilirubin) elevations at screening above 2 × the ULN.
  16. Clinically significant renal impairment defined as estimated creatinine clearance [CrCl] <50 mL/min at screening measured using Cockcroft-Gault formula.
  17. Fasting serum glucose >140 mg/dL.
  18. Subjects who, in the opinion of the Investigator, are not appropriate for a 21-day placebo-controlled study due to risk of significant threat to self or others during screening or study conduct.
  19. Previous participation in an investigational study using CERC-301.
  20. Participation in an investigational drug or device study within the 6 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CERC-301 12mg
The study includes two dose administrations 7 days apart (Day 0 and Day 7) followed by 14 days of observation for a total of 21 days.
Drug: CERC-301
CERC-301, a highly selective, orally bioavailable, NMDA receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist
EXPERIMENTAL: CERC-301 20mg
The study includes two dose administrations 7 days apart (Day 0 and Day 7) followed by 14 days of observation for a total of 21 days.
Drug: CERC-301
CERC-301, a highly selective, orally bioavailable, NMDA receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist
PLACEBO_COMPARATOR: Placebo
The study includes two dose administrations 7 days apart (Day 0 and Day 7) followed by 14 days of observation for a total of 21 days.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Bech-6 from baseline
Time Frame: average of 2 and 4 days post-treatment
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)
average of 2 and 4 days post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Santen-7
Time Frame: averaged between 2 and 4 days post treatment
To evaluate the antidepressant effect of a single dose of CERC-301 (12 or 20 mg) compared to placebo averaged between 2 and 4 days post-treatment with study drug assessed by the 7-item unidimensional subset of the HDRS-17, the Santen-7
averaged between 2 and 4 days post treatment
Change from baseline in HDRS-17
Time Frame: averaged between 2 and 4 days post treatment
To evaluate the antidepressant effect of a single dose of CERC-301 (12 or 20 mg) compared to placebo averaged between 2 and 4 days post-treatment with study drug assessed by the HDRS-17
averaged between 2 and 4 days post treatment
Change from baseline in Bech-6
Time Frame: 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment assessed by the Bech-6.
2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
Change from baseline in Santen-7
Time Frame: 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment assessed by the Santen-7.
2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
Change from baseline in HDRS-17
Time Frame: 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment assessed by the HDRS-17.
2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
Change from baseline in CUDOS-A
Time Frame: 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment assessed by the Clinically Useful Depression Outcome Scale-Anxiety (CUDOS-A).
2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
Change from baseline in SHAPS-SR
Time Frame: 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment assessed by the Snaith-Hamilton Pleasure Scale Self Report (SHAPS-SR)
2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
Change from baseline in QIDS-SR
Time Frame: 7 days after each dose and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 7 days after each dose and 14 days after last dose of study drug treatment assessed by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR)
7 days after each dose and 14 days after last dose of study drug treatment
Change from baseline in CGI-I
Time Frame: 7 days after each dose and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 7 days after each dose and 14 days after last dose of study drug treatment assessed by the Clinical Global Impression-Improvement (CGI-I)
7 days after each dose and 14 days after last dose of study drug treatment
Change from baseline in CGI-S
Time Frame: 7 days after each dose and 14 days after last dose of study drug treatment
To evaluate the antidepressant effect of CERC-301 at 7 days after each dose and 14 days after last dose of study drug treatment assessed by the Clinical Global Impression -Severity (CGI-S)
7 days after each dose and 14 days after last dose of study drug treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avalo Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ronald N Marcus, MD, Avalo Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Clin301-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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