NCT01234558CompletedPhase 2
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
Naurex, Inc, an affiliate of Allergan plc1 site in 1 country115 target enrollmentStarted: May 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Change in depression score
Study Overview
Brief Summary
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Normal Saline
Placebo Comparator
IV placebo
Intervention: GLYX-13 (Drug)
GLYX-13, 1 mg/kg
Experimental
Intervention: GLYX-13 (Drug)
GLYX-13, 5 mg/kg
Experimental
Intervention: GLYX-13 (Drug)
GLYX-13, 10 mg/kg
Experimental
Intervention: GLYX-13 (Drug)
Outcomes
Primary Outcomes
Change in depression score
Time Frame: 14 days
Secondary Outcomes
- Change in BPRS+(14 days)
Investigators
Study Sites (1)
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