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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05204940
Other study ID # 080/2017
Secondary ID R01MH114970R01MH
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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