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NMDA Modulation in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT04637620
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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Brief Summary:
Most of the current antidepressants for major depressive disorder (MDD) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. NMDA hypofunction has been implicated in the pathophysiology of depression. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an NMDA enhancer (NMDAE) in the treatment of MDD in the adults.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: NMDAE Drug: Sertraline Drug: Placebo Cap Phase 2

Detailed Description:
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 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 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 general adults by comparing with sertraline (a selective serotonin reuptake inhibitor [SSRI]) and placebo. The investigators will enroll non-elderly adult patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigators will biweekly measure clinical performances and side effects. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The efficacy of three groups will be compared.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NMDA Modulation in Major Depressive Disorder
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sertraline

Arms and Interventions
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Arm Intervention/treatment
Experimental: NMDAE
An NMDA enhancer
 Drug: NMDAE
Use of an NMDA enhancer for the treatment of MDD
Active Comparator: SSRI
Sertraline (selective serotonin reuptake inhibitor)
 Drug: Sertraline
Use of SSRI as an active comparator
Placebo Comparator: Placebo
Placebo
 Drug: Placebo Cap
Use of placebo as a comparator


Outcome Measures
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Primary Outcome Measures :
  1. Change in Hamilton Rating Scale for Depression [ Time Frame: week 0, 2, 4, 6, 8 ]
    Assessment of depressive symptoms Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.

  2. Change in Global Assessment of Functioning [ Time Frame: Week 0, 2, 4, 6, 8 ]
    Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.


Secondary Outcome Measures :
  1. Change in Perceived Stress Scale [ Time Frame: week 0, 2, 4, 6, 8 ]
    Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.

  2. Visual Analogue Scale (VAS) [ Time Frame: week 0, 2, 4, 6, 8 ]
    Assessment of pain Minimum value: 0, maximum value:10, the higher scores mean a worse outcome.

  3. Clinical Global Impression [ Time Frame: week 0, 2, 4, 6, 8 ]
  4. Quality of life (SF-36) [ Time Frame: week 0, 8 ]
  5. Visual Continuous Performance Test [ Time Frame: week 0, 8 ]
    Assessment of sustained attention

  6. Wisconsin Card Sorting Test [ Time Frame: week 0, 8 ]
    Assessment of abstract and shift set

  7. Logical Memory Test of the Wechsler Memory Scale [ Time Frame: week 0, 8 ]
    Assessment of episodic memory

  8. Digit Span [ Time Frame: week 0, 8 ]
    Assessment of verbal working memory

  9. Spatial Span [ Time Frame: week 0, 8 ]
    Assessment of nonverbal working memory

  10. Category Fluency [ Time Frame: week 0, 8 ]
    Assessment of speed of processing

  11. Trail Marking A [ Time Frame: week 0, 8 ]
    Assessment of speed of processing

  12. WAIS-III Digit Symbol-Coding [ Time Frame: week 0, 8 ]
    Assessment of speed of processing

  13. Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0 [ Time Frame: week 0, 8 ]
    Assessment of social cognition


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
  • 17-item Hamilton Rating Scale for Depression total score ≥ 18
  • Free of antidepressant drugs for at least 2 weeks
  • Agree to participate in the study and provide informed consent

Exclusion Criteria:

  • Current substance abuse or history of substance dependence in the past 6 months
  • History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
  • 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 severe adverse reaction to SSRIs
  • A treatment-resistant history (that is, they have failed to respond to two or more different classes of antidepressants with adequate dosage and treatment duration
  • A history of previously received electroconvulsive therapy
  • Inability to follow protocol
Contacts and Locations
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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): NCT04637620


Contacts
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Contact: Hsien-Yuan Lane, M.D., Ph.D 886 4 22052121 ext 1855 hylane@gmail.com

Locations
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Taiwan
Department of Psychiatry, China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Hsien-Yuan Lane, M.D., Ph.D    886 4 22052121 ext 1855    hylane@gmail.com   
Sponsors and Collaborators
China Medical University Hospital
Ministry of Science and Technology, Taiwan
More Information
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04637620    
Other Study ID Numbers: CMUH103-REC2-130
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
Major depressive disorder
NMDA
Selective serotonin reuptake inhibitor
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
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