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

NCT02067793 | Completed Phase 2

• 1 other identifier: NRX1074-C-201
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 12

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.

Conditions

Major Depressive Disorder

Keywords

NRX-1074; NMDA Receptor Modulator; Major Depressive Disorder; Glycine site modulator

Outcome Measures

Primary Outcomes (1)

• 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

  Change in Hamilton Depression Rating Scale HDRS-17

  Day 1, Day 3, Day 7, Day 14

Secondary Outcomes (3)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

NRX-1074 1 mg

EXPERIMENTAL

NRX-1074 1 mg, intravenous

Drug: NRX-1074 1 mg

NRX-1074 5 mg

EXPERIMENTAL

NRX-1074 5 mg, intravenous

Drug: NRX-1074 5 mg

NRX-1074 10 mg

EXPERIMENTAL

NRX-1074 10 mg, intravenous

Drug: NRX-1074 10 mg

Interventions

NRX-1074 1 mg DRUG

Single intravenous administration of 1 mg into arm on Day 0

Also known as: NRX-1074 IV single dose

NRX-1074 1 mg

Placebo DRUG

Single intravenous injection into the arm on Day 0

Also known as: NRX-1074 IV single dose

Placebo

NRX-1074 5 mg DRUG

Single intravenous injection of 5 mg into the arm on Day 0

Also known as: NRX-1074 IV single dose

NRX-1074 5 mg

NRX-1074 10 mg DRUG

Single intravenous injection of 10 mg into the arm on Day 0

Also known as: NRX-1074 IV single dose

NRX-1074 10 mg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Naurex, Inc, an affiliate of Allergan plc: lead

Study Sites (12)

Pacific Research Partners

Oakland, California, 94612, United States

Location

Psychiatric Medicine Associates

Skokie, Illinois, 60076, United States

Location

University of Kansas School of Medicine Clinical Trial Unit

Wichita, Kansas, 67214, United States

Location

Boston Clinical Trials, Inc.

Roslindale, Massachusetts, 02131, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

Mount Sinai School of Medicine

Elmsford, New York, 10523, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Research Strategies Memphis

Memphis, Tennessee, 38119, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Psychiatric Alliance of the Blue Ridge

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Medical Director

  Naurex, Inc, an affiliate of Allergan plc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-02

Locations

US (12)