Clinical trial NCT01234558: Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: depression
NMDA antagonist
treatment resistant
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Axis diagnosis of other psychiatric disorders
* Experiencing hallucinations, delusions, other psychotic symptomatology
* ECT during current episode

Primary outcomes:
measure: Change in depression score
timeFrame: 14 days
Secondary outcomes:
measure: Change in BPRS+
timeFrame: 14 days
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Mulitple
state: Illinois
Study officials:
affiliation: Naurex, Inc, an affiliate of Allergan plc
name: Ronald M Burch, MD, PhD
role: STUDY_DIRECTOR
affiliation: Artemis Clinical Research, San Diego CA
name: Vishaal Mehra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CNRI-LA, Pico Rivera CA
name: Raymond Manning, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lehigh Center for Clinical Research, Allentown PA
name: Paul Gross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lynn Health Sciences Institute, Oklahoma City OK
name: Surinder Randhawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CRI-WW, Philadelphia PA
name: David Greuner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CRI-WW Lordes Hospital, Willingboro NJ
name: David Krefetz, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: U Texas SW Medical Center, Dallas TX
name: Benji Kurian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Claghorn-Lesem Research Clinic, Houston TX
name: Michael Lesem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Center, Univ Kansas, Wichita KS
name: Matthew Macaluso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinilabs, New York, NY
name: Stephen Murray, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.