RecruitingPhase 2NCT05136755

NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder

Sponsor

China Medical University Hospital

Enrollment

50 participants

Start Date

Jan 25, 2022

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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
item Hamilton Rating Scale for Depression total score ≥ 18
Agree to participate in the study and provide informed consent

Exclusion Criteria8

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