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Recruiting Phase 2

NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder

NCT05136755 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2022-01-25
Last updated
2026-10-23

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

NMDAE →Placebo Cap

NMDAE: Use of an NMDA enhancer for the treatment of antidepressant nonresponders with MDD

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. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of antidepressant nonresponders with MDD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of MDD * Have failed to respond to at least one antidepressant with adequate dosage and treatment duration * Their original treatments should have been unchanged for at least 8 weeks. Some treatment-resistant patients (that is, having failed to respond to at least two different classes of antidepressants) who have started to refuse any antidepressant by themselves due to previous failure experience are also allowed, if they have already been antidepressant-free for at least 2 weeks * 17-item Hamilton Rating Scale for Depression total score ≥ 18 * 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 disorder, 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 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)

FacilityCityRegionStatus
Department of Psychiatry, China Medical University Hospital Taichung Taiwan Recruiting
Official registry record

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.

View NCT05136755 on ClinicalTrials.gov ↗ ← All trials in China