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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GLYX-13

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, NMDA antagonist, treatment resistant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mulitple

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Normal Saline

GLYX-13, 1 mg/kg

GLYX-13, 5 mg/kg

GLYX-13, 10 mg/kg

Arm Description

IV placebo

Outcomes

Primary Outcome Measures

Change in depression score

Secondary Outcome Measures

Change in BPRS+

Full Information

NCT ID

NCT01234558

First Posted

November 3, 2010

Last Updated

September 10, 2012

Sponsor

Naurex, Inc, an affiliate of Allergan plc

1. Study Identification

Unique Protocol Identification Number

NCT01234558

Brief Title

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

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Naurex, Inc, an affiliate of Allergan plc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

depression, NMDA antagonist, treatment resistant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Arm Description

IV placebo

Arm Title

GLYX-13, 1 mg/kg

Arm Type

Experimental

Arm Title

GLYX-13, 5 mg/kg

Arm Type

Experimental

Arm Title

GLYX-13, 10 mg/kg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

GLYX-13

Other Intervention Name(s)

ThrProProThr

Intervention Description

single IV dose

Primary Outcome Measure Information:

Title

Change in depression score

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Change in BPRS+

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials: