Most of the current antidepressants for major depressive disorder (MDD) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. NMDA hypofunction has been implicated in the pathophysiology of depression. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an NMDA enhancer (NMDAE) in the treatment of MDD in the adults.
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 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 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 general adults by comparing with sertraline (a selective serotonin reuptake inhibitor \[SSRI\]) and placebo. The investigators will enroll non-elderly adult patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigators will biweekly measure clinical performances and side effects. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The efficacy of three groups will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Use of an NMDA enhancer for the treatment of MDD
Use of SSRI as an active comparator
Use of placebo as a comparator
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
RECRUITINGChange in Hamilton Rating Scale for Depression
Assessment of depressive symptoms Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6, 8
Change in Global Assessment of Functioning
Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.
Time frame: Week 0, 2, 4, 6, 8
Change in Perceived Stress Scale
Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6, 8
Visual Analogue Scale (VAS)
Assessment of pain Minimum value: 0, maximum value:10, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6, 8
Clinical Global Impression
Time frame: week 0, 2, 4, 6, 8
Quality of life (SF-36)
Time frame: week 0, 8
Visual Continuous Performance Test
Assessment of sustained attention
Time frame: week 0, 8
Wisconsin Card Sorting Test
Assessment of abstract and shift set
Time frame: week 0, 8
Logical Memory Test of the Wechsler Memory Scale
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Assessment of episodic memory
Time frame: week 0, 8
Digit Span
Assessment of verbal working memory
Time frame: week 0, 8
Spatial Span
Assessment of nonverbal working memory
Time frame: week 0, 8
Category Fluency
Assessment of speed of processing
Time frame: week 0, 8
Trail Marking A
Assessment of speed of processing
Time frame: week 0, 8
WAIS-III Digit Symbol-Coding
Assessment of speed of processing
Time frame: week 0, 8
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0
Assessment of social cognition
Time frame: week 0, 8