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NCT Number: NCT03414931

NMDA Modulation in Major Depressive Disorder in Late- Life

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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NMDA

Drug

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

Other names: NMDAE

Sertraline

Drug

Use of SSRI as an active comparator

Placebo - Cap

Drug

Use of placebo as a comparator

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2018
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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