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

Allergan

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: GLYX-13

Study type: Interventional

Funder types: Industry

Identifiers

NCT01234558

GLYX13-C201

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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115 participants in 4 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

IV placebo

Treatment:

Drug: GLYX-13

GLYX-13, 1 mg/kg

Experimental group

Treatment:

Drug: GLYX-13

GLYX-13, 5 mg/kg

Experimental group

Treatment:

Drug: GLYX-13

GLYX-13, 10 mg/kg

Experimental group

Treatment:

Drug: GLYX-13