NMDA Modulation in Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NMDAE

An NMDA enhancer

Group Type EXPERIMENTAL

NMDAE

Intervention Type DRUG

Use of an NMDA enhancer for the treatment of MDD

SSRI

Sertraline (selective serotonin reuptake inhibitor)

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

Use of SSRI as an active comparator

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Cap

Intervention Type DRUG

Use of placebo as a comparator

Interventions

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NMDAE

Use of an NMDA enhancer for the treatment of MDD

Intervention Type DRUG

Sertraline

Use of SSRI as an active comparator

Intervention Type DRUG

Placebo Cap

Use of placebo as a comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No