NCT05136755

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 major-depressive-disorder

Timeline
7mo left

Started Jan 2022

Longer than P75 for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jan 2022Dec 2026

First Submitted

Initial submission to the registry

November 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4.8 years

First QC Date

November 16, 2021

Last Update Submit

February 16, 2025

Conditions

Major Depressive Disorder

Keywords

Major depressive disorderAntidepressant nonrespondersNMDA

Outcome Measures

Primary Outcomes (2)

  • Change in Hamilton Rating Scale for Depression

    Assessment of depressive symptoms Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.

    week 0, 2, 4, 6, 8

  • Change in Global Assessment of Functioning

    Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.

    Week 0, 2, 4, 6, 8

Secondary Outcomes (13)

  • Change Change in Perceived Stress Scalein Perceived Stress Scale

    week 0, 2, 4, 6, 8

  • Visual Analogue Scale for pain

    week 0, 2, 4, 6, 8

  • Clinical Global Impression

    week 0, 2, 4, 6, 8

  • Quality of life (SF-36)

    week 0, 8

  • Visual Continuous Performance Test

    week 0, 8

  • +8 more secondary outcomes

Study Arms (2)

NMDAE

EXPERIMENTAL

An NMDA enhancer

Drug: NMDAE

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Cap

Interventions

NMDAEDRUG

Use of an NMDA enhancer for the treatment of antidepressant nonresponders with MDD

NMDAE
Placebo CapDRUG

Use of placebo as a comparator

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

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

CONTACT

886 4 22052121hylane@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 29, 2021

Study Start

January 25, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

TW(1)