Using NMDA enhancers to help patients with major depressive disorder who don't respond to standard antidepressants
Official title: NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder
Run by China Medical University Hospital · NCT05136755 · Data updated 2026-11-12
This study is testing a new medication for people with major depression who haven't found relief from regular antidepressants to see if it can help them feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Status | Recruiting |
| Started | January 25, 2022 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT05136755 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults diagnosed with major depressive disorder who have failed to respond to at least one antidepressant.
✕Probably not a fit
Patients with bipolar disorder, schizophrenia, or other serious neurological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the efficacy and safety of an NMDA enhancer (NMDAE) in patients with major depressive disorder (MDD) who have not responded to traditional antidepressants. It aims to address the limitations of current treatments that are primarily based on the monoamine hypothesis, which does not fully explain depression's complexities. A total of 50 participants will be enrolled and randomly assigned to receive either NMDAE or a placebo, while continuing their existing treatments. Clinical performance will be assessed biweekly using various scales, and cognitive function will be evaluated at the beginning and end of the treatment period.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with MDD who have not benefited from existing antidepressants.
How similar studies have gone: While NMDA modulation is a novel approach in this context, similar studies have shown promise in exploring alternative mechanisms for treating depression.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan Recruiting
Study contacts
- Study coordinator: Hsien-Yuan Lane, M.D., Ph.D
- Email: hylane@gmail.com
- Phone: 886 4 22052121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.