Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder

Sponsor

Naurex, Inc, an affiliate of Allergan plc (Industry)

Overall Status

Completed

CT.gov ID

NCT02067793

Collaborator

(none)

151

Enrollment

Locations

Arms

11.1

Duration (Months)

12.6

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of NRX-1074 following a single intravenous dose in subjects with major depressive disorder.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: NRX-1074 1 mg Drug: Placebo Drug: NRX-1074 5 mg Drug: NRX-1074 10 mg	Phase 2

Detailed Description

NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate efficacy and safety of NRX-1074 at dose levels that are predicted by comparison of human and animal pharmacokinetics to be efficacious.

Study Design

Study Type:

Interventional

Actual Enrollment :

151 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 2, Randomized, Double-Blind, Multiple-Dose Level, Placebo Controlled, Single Intravenous Dose, Parallel Efficacy and Safety Study of NRX-1074 in Subjects With Major Depressive Disorder

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo Single intravenous injection into the arm on Day 0 Other Names: NRX-1074 IV single dose
Experimental: NRX-1074 1 mg NRX-1074 1 mg, intravenous	Drug: NRX-1074 1 mg Single intravenous administration of 1 mg into arm on Day 0 Other Names: NRX-1074 IV single dose
Experimental: NRX-1074 5 mg NRX-1074 5 mg, intravenous	Drug: NRX-1074 5 mg Single intravenous injection of 5 mg into the arm on Day 0 Other Names: NRX-1074 IV single dose
Experimental: NRX-1074 10 mg NRX-1074 10 mg, intravenous	Drug: NRX-1074 10 mg Single intravenous injection of 10 mg into the arm on Day 0 Other Names: NRX-1074 IV single dose

Outcome Measures

Primary Outcome Measures

To evaluate the mean change from baseline in Hamilton Depression Rating Scale 17 (HDRS-17) score for each NRX-1074 dose group versus the placebo group's mean change [Day 1, Day 3, Day 7, Day 14]
Change in Hamilton Depression Rating Scale HDRS-17

Secondary Outcome Measures

Change in Brief Psychiatric Rating Scale positive symptoms (BPRS+) scale [Day 1]
Change in Clinician Administered Dissociative States Scale (CADSS) [Day 1]
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female subjects
Aged 18 to 65 years
Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD)
Current episode has lasted ≥ 8 weeks before Screening
HDRS-17 score ≥ 21 before beginning the washout of all current antidepressant agents and/or adjuvant agents
HDRS-17 score ≥ 21 at Baseline (after 14 days of washout of current antidepressant agents)
Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal
Male subjects and their female sexual partner should use an acceptable method of birth control during the study
Clinical laboratory values < 2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor
Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
Based on both the investigator and Naurex medical monitor's clinical judgment, subjects with eating disorders, obsessive compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), and generalized anxiety disorders secondary to major depressive episodes are permitted

Exclusion Criteria:

Axis I diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder, agoraphobia, social phobia, attention-deficit hyperactivity disorder (ADHD), or PTSD
A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis
Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures or strokes
Currently hospitalized or residing in an in-patient facility during the study participation
Substance abuse within the last 12 months, including greater than or equal to 5 units of alcohol per day where 1 unit = 1/2 pint of beer, 1 glass of wine, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator
Allergy or intolerance to current antidepressant or other current medications
Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial
Positive screen for drugs of abuse: cocaine, marijuana, PCP, ketamine, opioid or other agent that in the opinion of the investigator is being abused
Have received electroconvulsive therapy, transcranial magnetic stimulation (TMS), or vagal nerve stimulation (VNS) for the current depressive episode
Post current (past 6 months) suicide risk based on administration of the C-SSRS and the investigator's clinical judgment
Human immunodeficiency virus (HIV) infection (based on the HIV-1 & HIV-2 antibody screen) or other ongoing infectious disease
Females or female partners of male subjects who are currently pregnant or planning to become pregnant during the course of the study. Women who are breastfeeding
Currently taking prescription (psychiatric treatments, antidepressant treatments) or over-the-counter medications including herbal therapies to treat their MDD or conditions secondary to their period following study drug dosing. Dextromethorphan or tramadol since these are serotonin uptake inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Research Partners	Oakland	California	United States	94612
2	Psychiatric Medicine Associates	Skokie	Illinois	United States	60076
3	University of Kansas School of Medicine Clinical Trial Unit	Wichita	Kansas	United States	67214
4	Boston Clinical Trials, Inc.	Roslindale	Massachusetts	United States	02131
5	Psychiatric Care and Research Center	O'Fallon	Missouri	United States	63368
6	Mount Sinai School of Medicine	Elmsford	New York	United States	10523
7	New York State Psychiatric Institute	New York	New York	United States	10032
8	Lindner Center of HOPE	Mason	Ohio	United States	45040
9	Research Strategies Memphis	Memphis	Tennessee	United States	38119
10	Research Across America	Dallas	Texas	United States	75234
11	Lifetree Clinical Research	Salt Lake City	Utah	United States	84106
12	Psychiatric Alliance of the Blue Ridge	Charlottesville	Virginia	United States	22903