Longitudinal Observational Biomarker Study

Depression Clinical Trial

— OPT-Neuro  

Official title:

Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05204940
• Other study ID #: 080/2017
• Secondary ID: R01MH114970R01MH
• Status: Active, not recruiting
• Start date: September 27, 2017
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function.

Description:

The purpose of this study is to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function. The study will also test if changes in brain structure and function are associated with decreases in memory. In this study, investigators will conduct a series of assessments/tests, mainly brain imaging and assessments of participant's memory and attention, to better understand how depression is linked to memory and thinking in older persons. Investigators hope that their study will help the scientific community to understand why some people with depressive symptoms that are resistant to treatment in late-life experience declines in their memory and attention and whether effective treatment of such depression reduces that risk. Finally, investigators hope that this study will eventually lead to the development of better treatment options.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged 60 and older

• Current Major Depressive Disorder (MDD)

• Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length

• Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher

Exclusion Criteria:

• Dementia

• Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.

• High risk for suicide and unable to be managed safely in the clinical trial

• Non-correctable, clinically significant sensory impairment interfering with participation

• Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.

• Moderate to severe substance or alcohol use disorder

• Seizure disorder.

• Parkinson's Disease

• Individuals with any contraindications to MRI

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Depression
• Mild Cognitive Impairment

Intervention

Behavioral:
• Mechanisms of Late life depression (LLD)-dementia through functional Magnetic Resonance Imaging (fMRI)
Analyzing mechanisms of the LLD-dementia relationship through fMRI acquisitions and analyses, to capture the specific brain networks implicated in executive function and episodic memory decline.
• Neuropsychological Data
Neuropsychological Data, including Montreal Cognitive Assessment (MoCA), Wide Range Achievement Test-4 (WRAT-4) Reading subtest, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Delis-Kaplan Executive Function System (D-KEFS) (Color Word Interference, Trail Making and Verbal Fluency).
• Clinical Scales
Clinical scales, including the Everyday Cognition Scale (E-Cog), Global Clinical Dementia Rating (CDR), Performance Assessment of Selfcare Skills (PASS)--CIADL (Cognitive Instrumental Activities of Daily Living) Short version, Patient Health Questionnaire (PHQ-9), and Suicide Risk Assessments (Suicide Questions, Baseline Suicidal Ideation, Suicide Intent Scale, Beck Lethality Scale, Decision Outcome Inventory, Columbia-Suicide Severity Rating Scale, and High Suicide Risk Protocol).

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
United States	UCLA Late-Life Mood, Stress, and Wellness Research Program	Los Angeles	California
United States	Columbia University Adult and Late Life Depression Clinic	New York	New York
United States	UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine Healthy Mind Lab	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	National Institute of Mental Health (NIMH), Patient-Centered Outcomes Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent Depression Leading to Change in Cognition	To test whether persistent (non-remitting) depression has the ability to change cognition and lead to greater cognitive decline, and greater degradation of neural circuitry	Baseline, 6-months, 24-months
Secondary	Change in Neural Circuity	To test whether greater degradation of neural circuitry is associated with greater cognitive decline	Baseline, 6-months, 24-months