NMDAE: Use of an NMDA enhancer for the treatment of MDD
Sertraline: Use of SSRI as an active comparator
Placebo Cap: Use of placebo as a comparator
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
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.
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.
Trial sites (1)
Facility
City
Region
Status
Department of Psychiatry, China Medical University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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