RecruitingPhase 2NCT04637620

NMDA Modulation in Major Depressive Disorder


Sponsor

China Medical University Hospital

Enrollment

90 participants

Start Date

Jun 1, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

  • Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
  • 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 Criteria10

  • 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

Interventions

DRUGSertraline

Use of SSRI as an active comparator

DRUGPlacebo Cap

Use of placebo as a comparator

DRUGNMDAE

Use of an NMDA enhancer for the treatment of MDD


Locations(1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

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NCT04637620


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