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NMDA Modulation in Major Depressive Disorder in Late- Life

NCT ID: NCT03414931

Last Updated: 2020-12-01

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-11-30

Brief Summary

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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 elderly 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 in the elderly 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 elderly by comparing with sertraline (a selective serotonin reuptake inhibitor \[SSRI\]) and placebo.

The investigator will enroll elderly patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigator will biweekly measure clinical performances. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The investigator hypothesize that NMDAE can safely yield better efficacy than placebo and sertraline for elderly patients with MDD.

Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NMDAE

An NMDA enhancer

Group Type EXPERIMENTAL

NMDA

Intervention Type DRUG

Use of an NMDA enhancer for the treatment of MDD in late life

SSRI

Sertraline

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

Use of SSRI as an active comparator

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo - Cap

Intervention Type DRUG

Use of placebo as a comparator

Interventions

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NMDA

Use of an NMDA enhancer for the treatment of MDD in late life

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

Other Intervention Names

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NMDAE

Eligibility Criteria

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Inclusion Criteria

* Have a DSM-IV (American Psychiatric Association 1994) diagnosis of MDD
* 17-item Hamilton Rating Scale for Depression total score ≥ 18
* Free of psychotropic drugs for at least 2 weeks
* Have a Mini-Mental State Examination (Folstein, Folstein et al. 1975) score ≥ 20

Exclusion Criteria

* Current substance abuse or history of substance dependence in the past 6 months
* Use of depot antipsychotics in the past 6 months
* History of epilepsy, head trauma, stroke or other serious medical or neurological illness
* 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 poor response to SSRIs or other antidepressants
* A history of previously received electroconvulsive therapy
* A history of severe adverse reaction to SSRIs or other antidepressants
* Inability to follow protocol
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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Lin CH, Wang SH, Lane HY. Effects of Sodium Benzoate, a D-Amino Acid Oxidase Inhibitor, on Perceived Stress and Cognitive Function Among Patients With Late-Life Depression: A Randomized, Double-Blind, Sertraline- and Placebo-Controlled Trial. Int J Neuropsychopharmacol. 2022 Aug 4;25(7):545-555. doi: 10.1093/ijnp/pyac006.

Reference Type DERIVED
PMID: 35023557 (View on PubMed)

Other Identifiers

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101-0365A3

Identifier Type: -

Identifier Source: org_study_id