NCT04637620

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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 major-depressive-disorder

Timeline
7mo left

Started Jun 2017

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 Progress94%
Jun 2017Dec 2026

Study Start

First participant enrolled

June 1, 2017

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
6 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

9.4 years

First QC Date

October 11, 2020

Last Update Submit

February 16, 2025

Conditions

Major Depressive Disorder

Keywords

Major depressive disorderNMDASelective serotonin reuptake inhibitor

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 in Perceived Stress Scale

    week 0, 2, 4, 6, 8

  • Visual Analogue Scale (VAS)

    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 (3)

NMDAE

EXPERIMENTAL

An NMDA enhancer

Drug: NMDAE

SSRI

ACTIVE COMPARATOR

Sertraline (selective serotonin reuptake inhibitor)

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Cap

Interventions

NMDAEDRUG

Use of an NMDA enhancer for the treatment of MDD

NMDAE
SertralineDRUG

Use of SSRI as an active comparator

SSRI
Placebo CapDRUG

Use of placebo as a comparator

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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 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

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

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

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

October 11, 2020

First Posted

November 20, 2020

Study Start

June 1, 2017

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)