NMDA Modulation in Major Depressive Disorder in Late- Life

NCT03414931 | Completed Phase 2

• 1 other identifier: 101-0365A3
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (2)

• Change from baseline of 17-item Hamilton Rating Scale for Depression

  Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured biweekly.

  Week 0, 2, 4, 6, 8

• Change from baseline of Perceived Stress Scale

  Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured biweekly

  Week 0, 2, 4, 6, 8

Secondary Outcomes (5)

• Drop out rate

  Week 0, 2, 4, 6, 8

• Change from baseline of Geriatric Depression Scale

  Week 0, 2, 4, 6, 8

• Clinical Global Impression

  Week 2, 4, 6, 8

• Cognitive function

  Week 0, 8

• Change from baseline of Beck's Suicide Scale

  Week 0, 2, 4, 6, 8

Study Arms (3)

NMDAE

EXPERIMENTAL

An NMDA enhancer

Drug: NMDA

SSRI

ACTIVE COMPARATOR

Sertraline

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo - Cap

Interventions

NMDA DRUG

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

Also known as: NMDAE

NMDAE

Sertraline DRUG

Use of SSRI as an active comparator

SSRI

Placebo - Cap DRUG

Use of placebo as a comparator

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a DSM-IV (American Psychiatric Association 1994) diagnosis of MDD
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35023557 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

N-Methylaspartate; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Aspartic Acid; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 30, 2018
• Study Start: January 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

TW (2)