Conditions: Depression
Keywords: MDD Depression Treatment refractory Glutamate Riluzole Major depressive disorder psychopharmacology rilutek
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive disorder (TRD).

Detailed description:
This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, 8 week trial of adjunctive trial in treatment-resistant major depressive disorder (TRD). Preclinical studies have shown riluzole to modulate Glu release and clearance, and to have potent neuroprotective properties, promoting neuro-resiliency. Other preclinical data now also show the drug to have antidepressant-like effects in rodent models used to screen for antidepressant activity. In addition, several small open-label clinical studies further suggest riluzole has antidepressant and anxiolytic properties, even in patients who do not respond to standard monoaminergic antidepressant and anxiolytic medications.

Arms:
arm 1: Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks arm 2: Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks arm 3: Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks

Interventions: intervention 1: Riluzole intervention 2: placebo
Intervention descriptions: intervention 1: Riluzole 100mg PO intervention 2: placebo

Protocol document: