NCT01234558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_2 major-depressive-disorder

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

November 3, 2010

Last Update Submit

September 10, 2012

Conditions

Major Depressive Disorder

Keywords

depressionNMDA antagonisttreatment resistant

Outcome Measures

Primary Outcomes (1)

  • Change in depression score

    14 days

Secondary Outcomes (1)

  • Change in BPRS+

    14 days

Study Arms (4)

Normal Saline

PLACEBO COMPARATOR

IV placebo

Drug: GLYX-13

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

Interventions

GLYX-13DRUG

single IV dose

Also known as: ThrProProThr
GLYX-13, 1 mg/kgGLYX-13, 10 mg/kgGLYX-13, 5 mg/kgNormal Saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulitple

Evanston, Illinois, 60201, United States

Location

Related Publications (1)

  • 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.

    PMID: 25782764DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

GLYX-13 peptide

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ronald M Burch, MD, PhD

    Naurex, Inc, an affiliate of Allergan plc

    STUDY DIRECTOR

  • Vishaal Mehra, MD

    Artemis Clinical Research, San Diego CA

    PRINCIPAL INVESTIGATOR

  • Raymond Manning, MD

    CNRI-LA, Pico Rivera CA

    PRINCIPAL INVESTIGATOR

  • Paul Gross, MD

    Lehigh Center for Clinical Research, Allentown PA

    PRINCIPAL INVESTIGATOR

  • Surinder Randhawa, MD

    Lynn Health Sciences Institute, Oklahoma City OK

    PRINCIPAL INVESTIGATOR

  • David Greuner, MD

    CRI-WW, Philadelphia PA

    PRINCIPAL INVESTIGATOR

  • David Krefetz, DO

    CRI-WW Lordes Hospital, Willingboro NJ

    PRINCIPAL INVESTIGATOR

  • Benji Kurian, MD

    U Texas SW Medical Center, Dallas TX

    PRINCIPAL INVESTIGATOR

  • Michael Lesem, MD

    Claghorn-Lesem Research Clinic, Houston TX

    PRINCIPAL INVESTIGATOR

  • Matthew Macaluso, MD

    Clinical Research Center, Univ Kansas, Wichita KS

    PRINCIPAL INVESTIGATOR

  • Stephen Murray, MD PhD

    Clinilabs, New York, NY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

US(1)