Major Depressive DisorderPhase 2NCT02067793
Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder
A Phase 2 study testing NRX-1074 1 mg, NRX-1074 5 mg and NRX-1074 10 mg in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- NRX-1074 1 mg, NRX-1074 5 mg and NRX-1074 10 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2014to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Psychiatric Alliance of the Blue Ridge
Charlottesville, Virginia, 22903
Research Across America
Dallas, Texas, 75234
Mount Sinai School of Medicine
Elmsford, New York, 10523
Lindner Center of HOPE
Mason, Ohio, 45040
Research Strategies Memphis
Memphis, Tennessee, 38119
New York State Psychiatric Institute
New York, New York, 10032
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Pacific Research Partners
Oakland, California, 94612
Boston Clinical Trials, Inc.
Roslindale, Massachusetts, 02131
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Psychiatric Medicine Associates
Skokie, Illinois, 60076
University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, 67214
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- NRX-1074 1 mg, Placebo, NRX-1074 5 mg, NRX-1074 10 mg
- Keywords
- NRX-1074, NMDA Receptor Modulator, Major Depressive Disorder, Glycine site modulator
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRX-1074 1 mgDrug
Also called NRX-1074 IV single dose
Single intravenous administration of 1 mg into arm on Day 0
PlaceboDrug
Also called NRX-1074 IV single dose
Single intravenous injection into the arm on Day 0
NRX-1074 5 mgDrug
Also called NRX-1074 IV single dose
Single intravenous injection of 5 mg into the arm on Day 0
NRX-1074 10 mgDrug
Also called NRX-1074 IV single dose
Single intravenous injection of 10 mg into the arm on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| NRX-1074 1 mg | Experimental | NRX-1074 1 mg, intravenous Receives: Drug: NRX-1074 1 mg |
| NRX-1074 5 mg | Experimental | NRX-1074 5 mg, intravenous Receives: Drug: NRX-1074 5 mg |
| NRX-1074 10 mg | Experimental | NRX-1074 10 mg, intravenous Receives: Drug: NRX-1074 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1, Day 3, Day 7, Day 14
Secondary outcomes (3)
Change in Brief Psychiatric Rating Scale positive symptoms (BPRS+) scale
Measured: Day 1
Change in Clinician Administered Dissociative States Scale (CADSS)
Measured: Day 1
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Naurex, Inc, an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067793
- Sponsor's protocol ID
- NRX1074-C-201
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2014
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02067793
- Acronym / sponsor ID
- NRX1074-C-201
- Conditions
- Major Depressive Disorder
- Keywords
- NRX-1074, NMDA Receptor Modulator, Major Depressive Disorder, Glycine site modulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| NRX-1074 1 mg | Experimental | Drug: NRX-1074 1 mgNRX-1074 1 mg, intravenous |
| NRX-1074 5 mg | Experimental | Drug: NRX-1074 5 mgNRX-1074 5 mg, intravenous |
| NRX-1074 10 mg | Experimental | Drug: NRX-1074 10 mgNRX-1074 10 mg, intravenous |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRX-1074 1 mgAlso: NRX-1074 IV single doseSingle intravenous administration of 1 mg into arm on Day 0 | Drug | NRX-1074 1 mg |
| PlaceboAlso: NRX-1074 IV single doseSingle intravenous injection into the arm on Day 0 | Drug | Placebo |
| NRX-1074 5 mgAlso: NRX-1074 IV single doseSingle intravenous injection of 5 mg into the arm on Day 0 | Drug | NRX-1074 5 mg |
| NRX-1074 10 mgAlso: NRX-1074 IV single doseSingle intravenous injection of 10 mg into the arm on Day 0 | Drug | NRX-1074 10 mg |
Primary outcome
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
Time frame: Day 1, Day 3, Day 7, Day 14
Change in Hamilton Depression Rating Scale HDRS-17
3 secondary outcomes
Change in Brief Psychiatric Rating Scale positive symptoms (BPRS+) scale
Time frame: Day 1
Change in Clinician Administered Dissociative States Scale (CADSS)
Time frame: Day 1
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Naurex, Inc, an affiliate of Allergan plc
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRX-1074 1 mg, NRX-1074 5 mg and NRX-1074 10 mg in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 1, Day 3, Day 7, Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.