Major Depressive DisorderPhase 2NCT04637620
NMDA Modulation in Major Depressive Disorder
A Phase 2 study testing NMDAE and Sertraline in people with Major Depressive Disorder, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- NMDAE and Sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2017to Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
- 17-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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Psychiatry, China Medical University Hospital
Taichung
Hsien-Yuan Lane, M.D., Ph.D, 886 4 22052121 ext. 1855, hylane@gmail.com
About this study
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.
Read the detailed description
Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the general adults by comparing with sertraline (a selective serotonin reuptake inhibitor [SSRI]) and placebo. The investigators will enroll non-elderly adult patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigators will biweekly measure clinical performances and side effects. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The efficacy of three groups will be compared.
- Conditions
- Major Depressive Disorder
- Being tested
- NMDAE, Sertraline, Placebo Cap
- Keywords
- Major depressive disorder, NMDA, Selective serotonin reuptake inhibitor
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMDAEDrug
Use of an NMDA enhancer for the treatment of MDD
SertralineDrug
Use of SSRI as an active comparator
Placebo CapDrug
Use of placebo as a comparator
| Study group | Role | What they receive |
|---|---|---|
| NMDAE | Experimental | An NMDA enhancer Receives: Drug: NMDAE |
| SSRI | Active comparator | Sertraline (selective serotonin reuptake inhibitor) Receives: Drug: Sertraline |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Rating Scale for Depression
Assessment of depressive symptoms Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
Measured: 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.
Measured: Week 0, 2, 4, 6, 8
Secondary outcomes (13)
Change in Perceived Stress Scale
Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 8
Visual Analogue Scale (VAS)
Assessment of pain Minimum value: 0, maximum value:10, the higher scores mean a worse outcome.
Measured: week 0, 2, 4, 6, 8
Clinical Global Impression
Measured: week 0, 2, 4, 6, 8
Quality of life (SF-36)
Measured: week 0, 8
Visual Continuous Performance Test
Assessment of sustained attention
Measured: week 0, 8
Wisconsin Card Sorting Test
Assessment of abstract and shift set
Measured: week 0, 8
Logical Memory Test of the Wechsler Memory Scale
Assessment of episodic memory
Measured: week 0, 8
Digit Span
Assessment of verbal working memory
Measured: week 0, 8
Spatial Span
Assessment of nonverbal working memory
Measured: week 0, 8
Category Fluency
Assessment of speed of processing
Measured: week 0, 8
Trail Marking A
Assessment of speed of processing
Measured: week 0, 8
WAIS-III Digit Symbol-Coding
Assessment of speed of processing
Measured: week 0, 8
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0
Assessment of social cognition
Measured: week 0, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Jun 2017
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637620
- Sponsor's protocol ID
- CMUH103-REC2-130
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2020
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No