ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Intermittent Doses of CERC-301 in MDD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02459236
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Cerecor Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: CERC-301 Drug: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Intermittent Doses of CERC-301 in the Treatment of Subjects With Severe Depression Despite Antidepressant Treatment
Study Start Date : June 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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)

  8. 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)

  9. 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)

  10. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459236


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

Responsible Party: Cerecor Inc
ClinicalTrials.gov Identifier: NCT02459236     History of Changes
Other Study ID Numbers: Clin301-203
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms