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Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression

NCT ID: NCT01234558

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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depression NMDA antagonist treatment resistant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal Saline

IV placebo

Group Type PLACEBO_COMPARATOR

GLYX-13

Intervention Type DRUG

single IV dose

GLYX-13, 1 mg/kg

Group Type EXPERIMENTAL

GLYX-13

Intervention Type DRUG

single IV dose

GLYX-13, 5 mg/kg

Group Type EXPERIMENTAL

GLYX-13

Intervention Type DRUG

single IV dose

GLYX-13, 10 mg/kg

Group Type EXPERIMENTAL

GLYX-13

Intervention Type DRUG

single IV dose

Interventions

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GLYX-13

single IV dose

Intervention Type DRUG

Other Intervention Names

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ThrProProThr

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naurex, Inc, an affiliate of Allergan plc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald M Burch, MD, PhD

Role: STUDY_DIRECTOR

Naurex, Inc, an affiliate of Allergan plc

Vishaal Mehra, MD

Role: PRINCIPAL_INVESTIGATOR

Artemis Clinical Research, San Diego CA

Raymond Manning, MD

Role: PRINCIPAL_INVESTIGATOR

CNRI-LA, Pico Rivera CA

Paul Gross, MD

Role: PRINCIPAL_INVESTIGATOR

Lehigh Center for Clinical Research, Allentown PA

Surinder Randhawa, MD

Role: PRINCIPAL_INVESTIGATOR

Lynn Health Sciences Institute, Oklahoma City OK

David Greuner, MD

Role: PRINCIPAL_INVESTIGATOR

CRI-WW, Philadelphia PA

David Krefetz, DO

Role: PRINCIPAL_INVESTIGATOR

CRI-WW Lordes Hospital, Willingboro NJ

Benji Kurian, MD

Role: PRINCIPAL_INVESTIGATOR

U Texas SW Medical Center, Dallas TX

Michael Lesem, MD

Role: PRINCIPAL_INVESTIGATOR

Claghorn-Lesem Research Clinic, Houston TX

Matthew Macaluso, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center, Univ Kansas, Wichita KS

Stephen Murray, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinilabs, New York, NY

Locations

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Mulitple

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25782764 (View on PubMed)

Other Identifiers

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GLYX13-C201

Identifier Type: -

Identifier Source: org_study_id