NMDA Modulation in Major Depressive Disorder in Late- Life

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03414931

Collaborator

(none)

136

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Drug: NMDA Drug: Sertraline Drug: Placebo - Cap	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

NMDA Modulation in Major Depressive Disorder in Late- Life

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NMDAE An NMDA enhancer	Drug: NMDA Use of an NMDA enhancer for the treatment of MDD in late life Other Names: NMDAE
Active Comparator: SSRI Sertraline	Drug: Sertraline Use of SSRI as an active comparator
Placebo Comparator: Placebo Placebo	Drug: Placebo - Cap Use of placebo as a comparator

Arm

Intervention/Treatment

Experimental: NMDAE

An NMDA enhancer

Drug: NMDA

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

Other Names:

NMDAE

Active Comparator: SSRI

Sertraline

Drug: Sertraline

Use of SSRI as an active comparator

Placebo Comparator: Placebo

Placebo

Drug: Placebo - Cap

Use of placebo as a comparator

Outcome Measures

Primary Outcome Measures

Change from baseline of 17-item Hamilton Rating Scale for Depression [Week 0, 2, 4, 6, 8]
Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured biweekly.
Change from baseline of Perceived Stress Scale [Week 0, 2, 4, 6, 8]
Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured biweekly

Secondary Outcome Measures

Drop out rate [Week 0, 2, 4, 6, 8]
The rate of drop out
Change from baseline of Geriatric Depression Scale [Week 0, 2, 4, 6, 8]
Assessment of geriatric depressive symptoms. The Geriatric Depression Scale will be measured biweekly
Clinical Global Impression [Week 2, 4, 6, 8]
Assessment of global improvement
Cognitive function [Week 0, 8]
A battery of tests to assess the cognitive function including speed of processing (category fluency) and verbal and nonverbal working memory
Change from baseline of Beck's Suicide Scale [Week 0, 2, 4, 6, 8]
Assessment of suicidal symptoms. The Beck's Suicide Scale will be measured biweekly

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Kaohsiung		Taiwan	886
2	China Medical University Hospital	Taichung		Taiwan	404

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT03414931

Other Study ID Numbers:

101-0365A3

First Posted:

Jan 30, 2018

Last Update Posted:

Dec 1, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Sertraline

Study Results

No Results Posted as of Dec 1, 2020