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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941043
• Other study ID #: Clin301-201
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2013
• Last updated: December 19, 2017
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2017
• Source: Cerecor Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1357
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Suicidal Ideation

Intervention

Drug:
• CERC-301

Other:
• Placebo

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	Chicago Psychiatry Associates	Chicago	Illinois
United States	ProScience Research Group	Culver City	California
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Collaborative NeuroScience Network, Inc.	Garden Grove	California
United States	Behavioral Research Specialists	Glendale	California
United States	Clinical Neuroscience Solutions	Jacksonville	Florida
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Suburban Research Associates	Media	Pennsylvania
United States	Bioscience Research	Mount Kisco	New York
United States	Synergy Clinical Research Center	National City	California
United States	The Medical Research Network	New York	New York
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	PCRC	O'Fallon	Missouri
United States	Pacific Clinical Trials, LLC	Oakland	California
United States	Southern CA Psychiatrists	Oceanside	California
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Arizona TMS Therapy Center	Phoenix	Arizona
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Artemis Institute for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Cerecor Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HDRS-17 Averaged between 7 and 28 days of treatment with study drug	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.	Screening, Days 0, 4, 7, 11, 14, 21, 28, & 35
Secondary	HDRS-17 after 28 days of dosing with study drug	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.	Screening, Days 0, 4, 7, 11, 14, 21, 28, 35