NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital

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