- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02459236
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
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
115
Phase
- 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
-
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California
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Newport Beach, California, United States, 92660
- Pharmacology Research Institute (Pri)
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Georgia
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Alpharetta, Georgia, United States, 30005
- Institute for Advanced Medical Research
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Illinois
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Chicago, Illinois, United States, 60634
- Chicago Research Center, Inc.
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Hoffman Estates, Illinois, United States, 60169
- Alexian Brothers Center for Psychiatric Research
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Missouri
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O'Fallon, Missouri, United States, 63368
- Psychiatric Care and Research Center
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New York
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Mount Kisco, New York, United States, 10549
- Bioscience Research LLC
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New York, New York, United States, 10128
- The Medical Research Network, LLC
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Rochester, New York, United States, 14618
- Fingerlakes Clinical Research
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Staten Island, New York, United States, 10312
- Richmond Behavioral Associates
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Oregon
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Portland, Oregon, United States, 97201
- Summit Research Network (Oregon) Inc.
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Lehigh Center for Clinical Research
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Tennessee
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Memphis, Tennessee, United States, 38119
- Research Strategies of Memphis, LLC
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Washington
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Bellevue, Washington, United States, 98007
- Northwest Clinical Research Center
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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
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- Lifetime history of ≥2 major depressive episodes, for which at least one required treatment with SSRI or SNRI antidepressants.
- 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:
- Duration of current depression episode ≥2 years or diagnosis of Persistent Depressive Disorder (DSM-V) or Dysthymic Disorder (DSM-IV)
- Use of other NMDA-receptor modulators (e.g., dextromethorphan, ketamine, amantadine, memantine) within 30 days of screening and throughout the study.
- History of use of an NMDA-receptor modulator for the treatment of MDD.
- Use of bupropion, tricyclic antidepressants, antipsychotics, stimulants, or lithium within 8 weeks prior to screening
- 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.
- Electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation during the current depressive episode.
- 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.
- 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.
- 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.).
- 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).
- 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.
- Subjects with suicidal behavior within 6 months prior to screening as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) "Baseline/Screening" version.
- Elevated seated blood pressure at screening and prior to randomization
- Lifetime history of stroke or congestive heart failure, atrial fibrillation or coronary artery disease.
- Clinically significant current liver disease or liver enzyme (GGT, ALT, AST, total bilirubin) elevations at screening above 2 × the ULN.
- Clinically significant renal impairment defined as estimated creatinine clearance [CrCl] <50 mL/min at screening measured using Cockcroft-Gault formula.
- Fasting serum glucose >140 mg/dL.
- 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.
- Previous participation in an investigational study using CERC-301.
- 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 |
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
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
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).
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2, 4, 7 days after each dose, and 14 days after last dose of study drug treatment
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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)
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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
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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
Investigators
- 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
June 1, 2015
Primary Completion (ACTUAL)
September 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
May 27, 2015
First Submitted That Met QC Criteria
June 1, 2015
First Posted (ESTIMATE)
June 2, 2015
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2017
Last Update Submitted That Met QC Criteria
September 25, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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