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GLYX-13/kg

Phase 2

Major Depressive Disorder | Small molecule | Other |AbbVie Inc.|Last Updated: Mar 17, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment484

FDA Designations

No designations recorded

Clinical trial landscape

GLYX-13/kg · 2 trials · 1 indication

Phase 2 2
NCT01684163Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to AntidepressantsMajor Depressive Disorder
COMPLETED369 Analytics
NCT01234558Single IV Dose of GLYX-13 in Patients With Treatment-Resistant DepressionMajor Depressive Disorder
COMPLETED115 Analytics
PHASE2COMPLETED
Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants
Major Depressive DisorderUnlock trial analytics
PHASE2COMPLETED
Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Hamilton Depression Rating Scale Score
6 weeks, 12 weeks, 16 weeks
Change in depression score
14 days

Secondary Endpoints

Clinical Global Impression of Change
6 weeks, 12 weeks, 16 weeks
Change in BPRS+
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo injectionPLACEBO_COMPARATORNormal saline
GLYX-13, 5 mg/kgEXPERIMENTALLow dose of GLYX-13
GLYX-13, 10 mg/kgEXPERIMENTALHigh dose of GLYX-13
Normal SalinePLACEBO_COMPARATORIV placebo
GLYX-13, 1 mg/kgEXPERIMENTAL -

Interventions

NameTypeDescription
GLYX-13 5 mg/kgDRUGIntravenous administration of 5 mg/kg into arm.
GLYX-13 10 mg/kgDRUGIntravenous administration of 10 mg/kg into arm.
PlaceboDRUGIntravenous administration of normal saline into arm.
GLYX-13DRUGsingle IV dose
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Male and female subjects * Aged 18 to 65 years * Meets DSM-IV-TR) criteria for major depressive disorder (MDD) * Current episode has lasted ≥ 8 weeks before Screening with an inadequate response to all approved antidepressant agent(s) administered at an adequate dose and durat...

Countries:United States
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