Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05136755

NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder

Led by China Medical University Hospital · Updated on 2025-02-19

50

Participants Needed

1

Research Sites

253 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a DSM-5 diagnosis of major depressive disorder
  • Have failed to respond to at least one antidepressant with adequate dosage and treatment duration
  • Original treatments unchanged for at least 8 weeks, or have been antidepressant-free for at least 2 weeks if treatment-resistant and refusing antidepressants
  • Hamilton Rating Scale for Depression score of 18 or higher
  • Agree to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Current substance abuse or substance dependence in the past 6 months
  • History of epilepsy, head trauma, stroke, or other serious medical or neurological illness that may interfere with the study
  • Bipolar disorder, schizophrenia, or other psychotic disorder
  • Moderate to severe suicidal risks
  • Severe cognitive impairment
  • Starting or stopping formal psychotherapy within 6 weeks before enrollment
  • History of electroconvulsive therapy
  • Inability to follow the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

Actively Recruiting

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Research Team

H

Hsien-Yuan Lane, M.D., Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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