Major Depressive DisorderPhase 2NCT01684163
Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants
A Phase 2 study testing GLYX-13 5 mg/kg and GLYX-13 10 mg/kg in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc at 26 sites in United States.
Trial summary
GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major depressive disorder (depression) who have responded inadequately to another antidepressant drug during the current episode. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- GLYX-13 5 mg/kg and GLYX-13 10 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 26 sitesUnited States
- Study dates
- Nov 2012to Jun 2014
- 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 75 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 DSM-IV-TR) criteria for major depressive disorder (MDD)
- Current episode has lasted ≥ 8 weeks before Screening with an inadequate response to all approved antidepressant agent(s) administered at an adequate dose and duration for the current episode
- Taking no antidepressant agent currently or taking an SSRI or SNRI
- HDRS-17 score ≥ 18 at screening and predose baseline
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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 and who do not plan to become pregnant during the course of 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 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 (MDEs) 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, acute stress 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
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- Women who are planning to become pregnant during the course of the study
- 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 with the exception of GLYX13-C-201.
- Positive screen for drugs of abuse
- Have received electroconvulsive therapy, transcranial magnetic stimulation (TMS), or vagal nerve stimulation (VNS) for the current depressive episode
- Pose 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 who are currently pregnant or planning to become pregnant during the course of the study
- Dextromethorphan or tramadol since these are serotonin uptake inhibitors
- History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor [NMDAR] ligands
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328
PharmaSite Research , Inc.
Baltimore, Maryland, 21208
University of Alabama Office of Psychiatric Clinical Research
Birmingham, Alabama, 35294
Chicago Research Center
Chicago, Illinois, 60634
University of Texas Southwestern Medical Center of Dallas
Dallas, Texas, 75235
Pharmacology Research Institute
Encino, California, 91316
Sarkis Clinical Trials
Gainesville, Florida, 32607
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46201
Pharmacology Research Institute
Los Alamitos, California, 90720
Pacific Institute of Medical Research
Los Angeles, California, 90024
CRI Lifetree
Marlton, New Jersey, 08054
Clinilabs, Inc.
New York, New York, 10019
Michael R Liebowitz MD
New York, New York, 10128
Pharmacology Research Institute
Newport Beach, California, 92660
Evanston Premier Healthcare Research, LLC
Northbrook, Illinois, 60201
CRI Lifetree
Phildadelphia, Pennsylvania, 19139
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210
Global Medical Institutes LLC
Princeton, New Jersey, 08540
Finger Lake Clinical Research
Rochester, New York, 14618
Bostin Clinical Trials, Inc.
Roslindale, Massachusetts, 02131
CRI Lifetree
Salt Lake City, Utah, 84106
Artemis Institute for Clinical Research
San Diego, California, 92103
Summit Research Network
Seattle, Washington, 98104
University of Kansas
Wichita, Kansas, 67211
About this study
Official title: Phase 2, Double-Blind, Placebo Controlled, Randomized Withdrawal, Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder
GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major depressive disorder (depression) who have responded inadequately to another antidepressant drug during the current episode. This trial will assess the effects of GLYX-13 on depression when added to another antidepressant drug that the patient is already taking.
Read the detailed description
To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal period).
- Conditions
- Major Depressive Disorder
- Being tested
- GLYX-13 5 mg/kg, GLYX-13 10 mg/kg, Placebo
- Keywords
- depression, MDD, GLYX-13, HDRS-17, HAMD-17
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLYX-13 5 mg/kgDrug
Also called GLYX-13 IV Dose
Intravenous administration of 5 mg/kg into arm.
GLYX-13 10 mg/kgDrug
Also called GLYX-13 IV Dose
Intravenous administration of 10 mg/kg into arm.
PlaceboDrug
Also called Normal Saline
Intravenous administration of normal saline into arm.
| Study group | Role | What they receive |
|---|---|---|
| Placebo injection | Placebo comparator | Normal saline Receives: Drug: Placebo |
| GLYX-13, 5 mg/kg | Experimental | Low dose of GLYX-13 Receives: Drug: GLYX-13 5 mg/kg |
| GLYX-13, 10 mg/kg | Experimental | High dose of GLYX-13 Receives: Drug: GLYX-13 10 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale Score
Measured: 6 weeks, 12 weeks, 16 weeks
Secondary outcomes (1)
Clinical Global Impression of Change
Measured: 6 weeks, 12 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionJun 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 369 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 affilate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684163
- Sponsor's protocol ID
- GLYX13-C-202
- Status last verified
- Feb 2016
- First submitted
- 10 Sep 2012
- 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, Double-Blind, Placebo Controlled, Randomized Withdrawal, Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01684163
- Acronym / sponsor ID
- GLYX13-C-202
- Conditions
- Major Depressive Disorder
- Keywords
- depression, MDD, GLYX-13, HDRS-17, HAMD-17
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Sep 2012 (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.
GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major depressive disorder (depression) who have responded inadequately to another antidepressant drug during the current episode. This trial will assess the effects of GLYX-13 on depression when added to another antidepressant drug that the patient is already taking.
Detailed description
To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo injection | Placebo comparator | Drug: PlaceboNormal saline |
| GLYX-13, 5 mg/kg | Experimental | Drug: GLYX-13 5 mg/kgLow dose of GLYX-13 |
| GLYX-13, 10 mg/kg | Experimental | Drug: GLYX-13 10 mg/kgHigh dose of GLYX-13 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects
- Aged 18 to 65 years
- Meets DSM-IV-TR) criteria for major depressive disorder (MDD)
- Current episode has lasted ≥ 8 weeks before Screening with an inadequate response to all approved antidepressant agent(s) administered at an adequate dose and duration for the current episode
- Taking no antidepressant agent currently or taking an SSRI or SNRI
Key exclusion criteria (16 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, acute stress 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 |
|---|---|---|
| GLYX-13 5 mg/kgAlso: GLYX-13 IV DoseIntravenous administration of 5 mg/kg into arm. | Drug | GLYX-13, 5 mg/kg |
| GLYX-13 10 mg/kgAlso: GLYX-13 IV DoseIntravenous administration of 10 mg/kg into arm. | Drug | GLYX-13, 10 mg/kg |
| PlaceboAlso: Normal SalineIntravenous administration of normal saline into arm. | Drug | Placebo injection |
Primary outcome
Change in Hamilton Depression Rating Scale Score
Time frame: 6 weeks, 12 weeks, 16 weeks
1 secondary outcome
Clinical Global Impression of Change
Time frame: 6 weeks, 12 weeks, 16 weeks
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 affilate of Allergan plc
26 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 GLYX-13 5 mg/kg and GLYX-13 10 mg/kg in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc at 26 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 10 inclusion and 16 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 26 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?
Change in Hamilton Depression Rating Scale Score (time frame: 6 weeks, 12 weeks, 16 weeks). 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.