NCT04637620 NMDA Modulation in Major Depressive Disorder
| NCT ID | NCT04637620 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | China Medical University Hospital |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2017-06-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2017-06-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04637620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04637620 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04637620 currently recruiting?
Yes, NCT04637620 is actively recruiting participants. Contact the research team at hylane@gmail.com for enrollment information.
Where is the NCT04637620 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT04637620 clinical trial?
NCT04637620 is sponsored by China Medical University Hospital. The trial plans to enroll 90 participants.