Major Depressive DisorderPhase 2NCT01234558
Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression
A Phase 2 study testing GLYX-13 in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc at 1 site in United States.
Trial summary
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression. 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?
- GLYX-13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jul 2012
- 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
- diagnosis of major depressive disorder consistent with DSM-IV-TR
- current episode greater than 8 weeks in duration
- Hamilton Depression score >/- 21
- less than 25% reduction in depression during current episode assessed by ATRQ
Who cannot join
- Axis diagnosis of other psychiatric disorders
- Experiencing hallucinations, delusions, other psychotic symptomatology
- ECT during current episode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Placebo Controlled, Single IV Dose Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
- Conditions
- Major Depressive Disorder
- Being tested
- GLYX-13
- Keywords
- depression, NMDA antagonist, treatment resistant
- 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-13Drug
Also called ThrProProThr
single IV dose
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | IV placebo Receives: Drug: GLYX-13 |
| GLYX-13, 1 mg/kg | Experimental | Not described Receives: Drug: GLYX-13 |
| GLYX-13, 5 mg/kg | Experimental | Not described Receives: Drug: GLYX-13 |
| GLYX-13, 10 mg/kg | Experimental | Not described Receives: Drug: GLYX-13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression score
Measured: 14 days
Secondary outcomes (1)
Change in BPRS+
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald M Burch, MD, PhD, Study director, Naurex, Inc, an affiliate of Allergan plcVishaal Mehra, MD, Principal investigator, Artemis Clinical Research, San Diego CARaymond Manning, MD, Principal investigator, CNRI-LA, Pico Rivera CAPaul Gross, MD, Principal investigator, Lehigh Center for Clinical Research, Allentown PASurinder Randhawa, MD, Principal investigator, Lynn Health Sciences Institute, Oklahoma City OKDavid Greuner, MD, Principal investigator, CRI-WW, Philadelphia PADavid Krefetz, DO, Principal investigator, CRI-WW Lordes Hospital, Willingboro NJBenji Kurian, MD, Principal investigator, U Texas SW Medical Center, Dallas TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234558
- Sponsor's protocol ID
- GLYX13-C201
- Status last verified
- Sep 2012
- First submitted
- 3 Nov 2010
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93.
PubMed 25782764
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled, Single IV Dose 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
- NCT01234558
- Acronym / sponsor ID
- GLYX13-C201
- Conditions
- Major Depressive Disorder
- Keywords
- depression, NMDA antagonist, treatment resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Nov 2010 (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 determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
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 |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: GLYX-13IV placebo |
| GLYX-13, 1 mg/kg | Experimental | Drug: GLYX-13 |
| GLYX-13, 5 mg/kg | Experimental | Drug: GLYX-13 |
| GLYX-13, 10 mg/kg | Experimental | Drug: GLYX-13 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of major depressive disorder consistent with DSM-IV-TR
- current episode greater than 8 weeks in duration
- Hamilton Depression score >/- 21
- less than 25% reduction in depression during current episode assessed by ATRQ
Key exclusion criteria (3 listed)
- Axis diagnosis of other psychiatric disorders
- Experiencing hallucinations, delusions, other psychotic symptomatology
- ECT during current episode
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-13Also: ThrProProThrsingle IV dose | Drug | GLYX-13, 1 mg/kg, GLYX-13, 10 mg/kg, GLYX-13, 5 mg/kg, Normal Saline |
Primary outcome
Change in depression score
Time frame: 14 days
1 secondary outcome
Change in BPRS+
Time frame: 14 days
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 12 Sep 2012.
- Derived from this study: PubMed 25782764Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93.
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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.
Ronald M Burch, MD, PhD study director
Naurex, Inc, an affiliate of Allergan plc
Vishaal Mehra, MD principal investigator
Artemis Clinical Research, San Diego CA
Raymond Manning, MD principal investigator
CNRI-LA, Pico Rivera CA
1 site 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 in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc at 1 site 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 4 inclusion and 3 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 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 depression score (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234558, which also lists 1 linked publication.
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 12 Sep 2012.