Exploring NMDA modulation for treating major depressive disorder
NMDA Modulation in Major Depressive Disorder
This study is testing a new treatment for major depressive disorder to see if it works better than a common antidepressant and a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT04637620 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of an NMDA enhancer (NMDAE) in treating major depressive disorder (MDD) in adults, comparing it to sertraline, a selective serotonin reuptake inhibitor, and a placebo. The trial will enroll non-elderly adult patients diagnosed with MDD and will last for 8 weeks, during which participants will be randomly assigned to one of the three treatment groups. Clinical performance and side effects will be monitored biweekly, while cognitive functions will be assessed at the beginning and end of the treatment period. The goal is to determine if NMDAE can improve both depressive symptoms and cognitive function compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are non-elderly adults diagnosed with major depressive disorder who have not been on antidepressant medications for at least two weeks.
Not a fit: Patients with bipolar disorder, schizophrenia, severe cognitive impairment, or those with a history of treatment resistance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that not only alleviates depressive symptoms but also enhances cognitive function in patients with MDD.
How similar studies have performed: Previous studies have shown cognitive improvements with NMDA enhancers, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taichung
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.