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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cerecor Inc
ClinicalTrials.gov Identifier:
NCT01941043
First received: September 5, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: CERC-301
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cerecor Inc:

Primary Outcome Measures:
  • HDRS-17 after 7 days of dosing with study drug [ Time Frame: Screening & Days 0, 4, 7, 11, 14, 21,28, & 35 ] [ Designated as safety issue: No ]
    The overall between-treatment difference will be computed as the weighted average of the differences (drug vs. placebo)


Secondary Outcome Measures:
  • HDRS-17 Averaged between 7 and 28 days of treatment with study drug [ Time Frame: Screening, Days 0, 4, 7, 11, 14, 21, 28, & 35 ] [ Designated as safety issue: No ]
    This will be analyzed using the mixed effects model for repeated measures. The between-group (drug vs. placebo) differences will be estimated by the least squares mean for the contrast in the main effect.

  • HDRS-17 after 28 days of dosing with study drug [ Time Frame: Screening, Days 0, 4, 7, 11, 14, 21, 28, 35 ] [ Designated as safety issue: No ]
    This will be analyzed using the mixed effects model for repeated measures . The between-group difference will be estimates by the least squares mean difference at Day 28 as a simple contrast from the model.


Estimated Enrollment: 135
Study Start Date: November 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CERC-301, Treatment Sequence 1
Treatment Sequence 1 - 7 days on placebo and 28 days on study drug (either 12mg or 8mg)
Drug: CERC-301 Other: Placebo
Experimental: CERC-301, Treatment Sequence 2
Treatment Sequence 2 - Placebo for 7 days and study drug for 28 days (8 mgs)
Drug: CERC-301 Other: Placebo
Placebo Comparator: Placebo, Treatment Sequence 3
Treatment Sequence 3 - Placebo for 35 Day treatment period
Drug: CERC-301 Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18 to 70 years of age inclusive.
  2. Females must be either:

    1. Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
    2. Women of childbearing potential (WOCBP) meeting the criteria below:

    i. Uses an acceptable double-barrier method of contraception as determined by the Investigator -and- ii. Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to randomization on Day 0.

  3. Male subjects must agree to use a condom if partner is of childbearing potential.
  4. Diagnosis of MDD recurrent without psychotic features according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria with diagnosis confirmed using the Structured Clinical Interview for DSM-IV Axis I Disorders Clinical Trials Version (SCID-CT).
  5. Currently adhering to antidepressant drug regimen that consists of stable SSRI or SNRI therapy
  6. Inadequate antidepressant response to current antidepressant therapy despite adequate dose and duration
  7. HDRS-17 score ≥ 21 on the HDRS-17 performed by the site at screening
  8. Recent active suicidal ideation defined as a score of 2 on the intensity of ideation section on the Columbia-Suicide Severity Rating Scale (C-SSRS) during the four weeks prior to screening using the "Baseline/Screening" version of the C-SSRS.
  9. In otherwise good general health without any unstable medical conditions (as determined by medical history, physical examination, 12-lead ECG, clinical laboratory testing, etc.).

Exclusion Criteria:

  1. History of substance abuse or dependence within the 3 months prior to screening.
  2. Positive urine drug test at screening and prior to randomization on Day 0 unless due to a permitted medication that is documented in the subject's medication history.
  3. Positive ethanol breath test at screening and/or prior to randomization on Day 0.
  4. Elevated semi-recumbent blood pressure at screening and prior to randomization on Day 0, defined as systolic blood pressure > 140 mm Hg and diastolic blood pressure
  5. 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, unstable angina, coronary artery disease, congestive heart failure, etc.).
  6. Subjects with clinical laboratory test abnormality deemed clinically significant by the Investigator at screening.
  7. Axis I diagnosis of obsessive compulsive disorder, posttraumatic stress disorder, bipolar I or II mood disorders, eating disorders (e.g., anorexia nervosa, bulimia nervosa), psychotic disorders (e.g., schizoaffective disorder, schizophrenia), significant cognitive disorders (e.g., delirium, dementia, amnesia), or dissociative disorders.
  8. Subjects with Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
  9. Subjects with a neurologic disorder that could cause or contribute to depression (e.g., Alzheimer's disease, Parkinson's disease).
  10. Female subjects currently experiencing postpartum depression.
  11. Subjects who, in the opinion of the Investigator, are not appropriate for a 35-day placebo-controlled study due to risk of significant threat to self or others during screening or study conduct.
  12. Use of other NMDA-receptor modulators (e.g., dextromethorphan, ketamine, amantadine, memantine) within 30 days of screening and throughout the study.
  13. The following concomitant medication use is excluded within six weeks prior to screening:

    • Bupropion or tricyclic antidepressants
    • Intermittent, symptomatic use of benzodiazepines (e.g. symptomatic treatment of anxiety or panic attacks)
    • Antipsychotics
    • Lithium
    • Any medications known to directly interact with central or peripheral serotonergic receptors, other than the permitted antidepressants.
    • Any medications known to directly interact with central noradrenergic receptors, other than the permitted antidepressants.
  14. Electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation during the current depressive episode.
  15. Participation in an investigational drug or device study within the 6 months prior to screening.
  16. Subjects with suicidal behavior within 6 months prior to screening as measured by the C-SSRS "Baseline/Screening" version.
  17. Subjects with a C-SSRS score > 2 on the intensity of ideation section at randomization (Visit 2a), using the "Since Last Visit" version of the C-SSRS.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941043

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona TMS Therapy Center
Phoenix, Arizona, United States, 85032
United States, California
ProScience Research Group
Culver City, California, United States, 90230
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States, 92845
Behavioral Research Specialists
Glendale, California, United States, 91206
Synergy Clinical Research Center
National City, California, United States, 91950
Kaiser Permanente Medical Center
Oakland, California, United States, 94612
Southern CA Psychiatrists
Oceanside, California, United States, 92056
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
United States, Florida
Clinical Neuroscience Solutions
Jacksonville, Florida, United States, 32256
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
Clinical Neuroscience Solutions
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
United States, Illinois
Chicago Psychiatry Associates
Chicago, Illinois, United States, 60602
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21285
United States, Missouri
PCRC
O'Fallon, Missouri, United States, 63368
United States, New York
Bioscience Research
Mt. Kisco, New York, United States, 10549
The Medical Research Network
New York, New York, United States, 10128
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, Ohio
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States, 44718
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
United States, Texas
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Cerecor Inc
Investigators
Study Director: James Vornov, MD, PhD Cerecor Inc
  More Information

No publications provided

Responsible Party: Cerecor Inc
ClinicalTrials.gov Identifier: NCT01941043     History of Changes
Other Study ID Numbers: Clin301-201
Study First Received: September 5, 2013
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Suicidal Ideation
Behavioral Symptoms
Mental Disorders
Mood Disorders
Self-Injurious Behavior
Suicide
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014