NMDA Modulation in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT04637620
- Lead Sponsor
- China Medical University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
- 17-item Hamilton Rating Scale for Depression total score ≥ 18
- Free of antidepressant drugs for at least 2 weeks
- Agree to participate in the study and provide informed consent
- Current substance abuse or history of substance dependence in the past 6 months
- History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
- Bipolar depression, schizophrenia or other psychotic disorder
- Moderate-severe suicidal risks
- Severe cognitive impairment
- Initiating or stopping formal psychotherapy within six weeks prior to enrollment
- A history of severe adverse reaction to SSRIs
- A treatment-resistant history (that is, they have failed to respond to two or more different classes of antidepressants with adequate dosage and treatment duration
- A history of previously received electroconvulsive therapy
- Inability to follow protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NMDAE NMDAE An NMDA enhancer Placebo Placebo Cap Placebo SSRI Sertraline Sertraline (selective serotonin reuptake inhibitor)
- Primary Outcome Measures
Name Time Method Change in Global Assessment of Functioning Week 0, 2, 4, 6, 8 Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.
Change in Hamilton Rating Scale for Depression week 0, 2, 4, 6, 8 Assessment of depressive symptoms Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method Wisconsin Card Sorting Test week 0, 8 Assessment of abstract and shift set
Category Fluency week 0, 8 Assessment of speed of processing
Trail Marking A week 0, 8 Assessment of speed of processing
WAIS-III Digit Symbol-Coding week 0, 8 Assessment of speed of processing
Visual Continuous Performance Test week 0, 8 Assessment of sustained attention
Change in Perceived Stress Scale week 0, 2, 4, 6, 8 Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.
Clinical Global Impression week 0, 2, 4, 6, 8 Visual Analogue Scale (VAS) week 0, 2, 4, 6, 8 Assessment of pain Minimum value: 0, maximum value:10, the higher scores mean a worse outcome.
Digit Span week 0, 8 Assessment of verbal working memory
Spatial Span week 0, 8 Assessment of nonverbal working memory
Quality of life (SF-36) week 0, 8 Logical Memory Test of the Wechsler Memory Scale week 0, 8 Assessment of episodic memory
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0 week 0, 8 Assessment of social cognition
Trial Locations
- Locations (1)
Department of Psychiatry, China Medical University Hospital
🇨🇳Taichung, Taiwan