drugset / Trial / NCT03414931

NMDA Modulation in Major Depressive Disorder in Late- Life

NCT03414931

Phase 2 Completed 136 enrolled Chang Gung Memorial Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many elderly patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD in the elderly is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the elderly by comparing with sertraline (a selective serotonin reuptake inhibitor \[SSRI\]) and placebo. The investigator will enroll elderly patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigator will biweekly measure clinical performances. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The investigator hypothesize that NMDAE can safely yield better efficacy than placebo and sertraline for elderly patients with MDD.

Timeline

Start
2016-01
Primary completion
2020-11
Completion
2020-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sertraline Small molecule 25 mg
Comparator Sertraline Small molecule 150 mg
Subject Sodium Benzoate Small molecule 250 mg
Subject Sodium Benzoate Small molecule 1500 mg