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

NCT01941043 | Completed Phase 2

• 1 other identifier: Clin301-201
• Study Type: interventional
• Target: 1,357
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• HDRS-17 after 7 days of dosing with study drug

  The overall between-treatment difference will be computed as the weighted average of the differences (drug vs. placebo)

  Screening & Days 0, 4, 7, 11, 14, 21,28, & 35

Secondary Outcomes (2)

• HDRS-17 Averaged between 7 and 28 days of treatment with study drug

  Screening, Days 0, 4, 7, 11, 14, 21, 28, & 35

• HDRS-17 after 28 days of dosing with study drug

  Screening, Days 0, 4, 7, 11, 14, 21, 28, 35

Study Arms (3)

CERC-301, Treatment Sequence 1

EXPERIMENTAL

Treatment Sequence 1 - 7 days on placebo and 28 days on study drug (either 12mg or 8mg)

Drug: CERC-301; Other: Placebo

CERC-301, Treatment Sequence 2

EXPERIMENTAL

Treatment Sequence 2 - Placebo for 7 days and study drug for 28 days (8 mgs)

Drug: CERC-301; Other: Placebo

Placebo, Treatment Sequence 3

PLACEBO COMPARATOR

Treatment Sequence 3 - Placebo for 35 Day treatment period

Other: Placebo

Interventions

CERC-301 DRUG

CERC-301, Treatment Sequence 1; CERC-301, Treatment Sequence 2

Placebo OTHER

CERC-301, Treatment Sequence 1; CERC-301, Treatment Sequence 2; Placebo, Treatment Sequence 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 to 70 years of age inclusive.
• Females must be either:
• Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
• 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.
• Male subjects must agree to use a condom if partner is of childbearing potential.
• 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).
• Currently adhering to antidepressant drug regimen that consists of stable SSRI or SNRI therapy
• Inadequate antidepressant response to current antidepressant therapy despite adequate dose and duration
• HDRS-17 score ≥ 21 on the HDRS-17 performed by the site at screening
• 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.
• In otherwise good general health without any unstable medical conditions (as determined by medical history, physical examination, 12-lead ECG, clinical laboratory testing, etc.).

You may not qualify if:

• History of substance abuse or dependence within the 3 months prior to screening.
• 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.
• Positive ethanol breath test at screening and/or prior to randomization on Day 0.
• 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
• 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.).
• Subjects with clinical laboratory test abnormality deemed clinically significant by the Investigator at screening.
• 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.
• Subjects with Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
• Subjects with a neurologic disorder that could cause or contribute to depression (e.g., Alzheimer's disease, Parkinson's disease).
• Female subjects currently experiencing postpartum depression.
• 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.
• Use of other NMDA-receptor modulators (e.g., dextromethorphan, ketamine, amantadine, memantine) within 30 days of screening and throughout the study.
• 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)

Sponsors & Collaborators

• Avalo Therapeutics, Inc.: lead

Study Sites (24)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona TMS Therapy Center

Phoenix, Arizona, 85032, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Collaborative NeuroScience Network, Inc.

Garden Grove, California, 92845, United States

Location

Behavioral Research Specialists

Glendale, California, 91206, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Pacific Clinical Trials, LLC

Oakland, California, 94612, United States

Location

Southern CA Psychiatrists

Oceanside, California, 92056, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

Clinical Neuroscience Solutions

Jacksonville, Florida, 32256, United States

Location

Scientific Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32806, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Chicago Psychiatry Associates

Chicago, Illinois, 60602, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

Location

PCRC

O'Fallon, Missouri, 63368, United States

Location

Bioscience Research

Mount Kisco, New York, 10549, United States

Location

The Medical Research Network

New York, New York, 10128, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• James Vornov, MD, PhD

  Avalo Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 13, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

US (24)