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
NCT ID: NCT01941043
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1357 participants
INTERVENTIONAL
2013-11-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CERC-301, Treatment Sequence 1
Treatment Sequence 1 - 7 days on placebo and 28 days on study drug (either 12mg or 8mg)
CERC-301
Placebo
CERC-301, Treatment Sequence 2
Treatment Sequence 2 - Placebo for 7 days and study drug for 28 days (8 mgs)
CERC-301
Placebo
Placebo, Treatment Sequence 3
Treatment Sequence 3 - Placebo for 35 Day treatment period
Placebo
Interventions
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CERC-301
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Avalo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James Vornov, MD, PhD
Role: STUDY_DIRECTOR
Avalo Therapeutics, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona TMS Therapy Center
Phoenix, Arizona, United States
ProScience Research Group
Culver City, California, United States
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States
Behavioral Research Specialists
Glendale, California, United States
Synergy Clinical Research Center
National City, California, United States
Pacific Clinical Trials, LLC
Oakland, California, United States
Southern CA Psychiatrists
Oceanside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Chicago Psychiatry Associates
Chicago, Illinois, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
PCRC
O'Fallon, Missouri, United States
Bioscience Research
Mount Kisco, New York, United States
The Medical Research Network
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Suburban Research Associates
Media, Pennsylvania, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Other Identifiers
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Clin301-201
Identifier Type: -
Identifier Source: org_study_id