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NMDA Modulation in Major Depressive Disorder in Late- Life

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ClinicalTrials.gov Identifier: NCT03414931
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sertraline

Arm Intervention/treatment
Experimental: NMDAE
An NMDA enhancer
Drug: NMDA
Use of an NMDA enhancer for the treatment of MDD in late life
Other Name: 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




Primary Outcome Measures :
  1. Change from baseline of 17-item Hamilton Rating Scale for Depression [ Time Frame: Week 0, 2, 4, 6, 8 ]
    Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured biweekly.

  2. Change from baseline of Perceived Stress Scale [ Time Frame: Week 0, 2, 4, 6, 8 ]
    Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured biweekly


Secondary Outcome Measures :
  1. Drop out rate [ Time Frame: Week 0, 2, 4, 6, 8 ]
    The rate of drop out

  2. Change from baseline of Geriatric Depression Scale [ Time Frame: Week 0, 2, 4, 6, 8 ]
    Assessment of geriatric depressive symptoms. The Geriatric Depression Scale will be measured biweekly

  3. Clinical Global Impression [ Time Frame: Week 2, 4, 6, 8 ]
    Assessment of global improvement

  4. Cognitive function [ Time Frame: Week 0, 8 ]
    A battery of tests to assess the cognitive function including speed of processing (category fluency) and verbal and nonverbal working memory

  5. Change from baseline of Beck's Suicide Scale [ Time Frame: Week 0, 2, 4, 6, 8 ]
    Assessment of suicidal symptoms. The Beck's Suicide Scale will be measured biweekly



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414931


Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 886
Contact: Chieh-Hsin Lin, MD, PhD    886-7-7317123 ext 8753    cyndi36@gmail.com   
Principal Investigator: Chieh-Hsin Lin, MD, PhD         
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Hsien-Yuan Lane, MD, PhD    886-921-067260    hylane@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03414931     History of Changes
Other Study ID Numbers: 101-0365A3
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs