NMDA Modulation in Major Depressive Disorder in Late- Life

Depressive Disorder, Major Clinical Trial

Official title:

NMDA Modulation in Major Depressive Disorder in Late- Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414931
• Other study ID #: 101-0365A3
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Drop out rate	The rate of drop out	Week 0, 2, 4, 6, 8
Secondary	Change from baseline of Geriatric Depression Scale	Assessment of geriatric depressive symptoms. The Geriatric Depression Scale will be measured biweekly	Week 0, 2, 4, 6, 8
Secondary	Clinical Global Impression	Assessment of global improvement	Week 2, 4, 6, 8
Secondary	Cognitive function	A battery of tests to assess the cognitive function including speed of processing (category fluency) and verbal and nonverbal working memory	Week 0, 8
Secondary	Change from baseline of Beck's Suicide Scale	Assessment of suicidal symptoms. The Beck's Suicide Scale will be measured biweekly	Week 0, 2, 4, 6, 8