NMDA Modulation in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

NMDA Modulation in Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637620
• Other study ID #: CMUH103-REC2-130
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2017
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: China Medical University Hospital
• Contact: Hsien-Yuan Lane, M.D., Ph.D
• Phone: 886 4 22052121
• Email: hylane[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• NMDAE
Use of an NMDA enhancer for the treatment of MDD
• Sertraline
Use of SSRI as an active comparator
• Placebo Cap
Use of placebo as a comparator

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Rating Scale for Depression	Assessment of depressive symptoms Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.	week 0, 2, 4, 6, 8
Primary	Change in Global Assessment of Functioning	Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.	Week 0, 2, 4, 6, 8
Secondary	Change in Perceived Stress Scale	Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.	week 0, 2, 4, 6, 8
Secondary	Visual Analogue Scale (VAS)	Assessment of pain Minimum value: 0, maximum value:10, the higher scores mean a worse outcome.	week 0, 2, 4, 6, 8
Secondary	Clinical Global Impression		week 0, 2, 4, 6, 8
Secondary	Quality of life (SF-36)		week 0, 8
Secondary	Visual Continuous Performance Test	Assessment of sustained attention	week 0, 8
Secondary	Wisconsin Card Sorting Test	Assessment of abstract and shift set	week 0, 8
Secondary	Logical Memory Test of the Wechsler Memory Scale	Assessment of episodic memory	week 0, 8
Secondary	Digit Span	Assessment of verbal working memory	week 0, 8
Secondary	Spatial Span	Assessment of nonverbal working memory	week 0, 8
Secondary	Category Fluency	Assessment of speed of processing	week 0, 8
Secondary	Trail Marking A	Assessment of speed of processing	week 0, 8
Secondary	WAIS-III Digit Symbol-Coding	Assessment of speed of processing	week 0, 8
Secondary	Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0	Assessment of social cognition	week 0, 8