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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01234558

Enrollment

115

Registered

2010-11-04

Start date

2011-05-31

Completion date

2012-07-31

Last updated

2012-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

depression, NMDA antagonist, treatment resistant

Brief summary

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

Interventions

DRUGGLYX-13

single IV dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change in depression score	14 days

Secondary

Measure	Time frame
Change in BPRS+	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026