Status:
COMPLETED
Longitudinal Observational Biomarker Study
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Patient-Centered Outcomes Research Institute
Conditions:
Depression
Dementia
Eligibility:
All Genders
60+ years
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT05204940
Start Date
September 27 2017
End Date
July 31 2024
Last Update
November 25 2024
Active Locations (5)
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1
UCLA Late-Life Mood, Stress, and Wellness Research Program
Los Angeles, California, United States, 90095
2
Washington University School of Medicine Healthy Mind Lab
St Louis, Missouri, United States, 63110
3
Columbia University Adult and Late Life Depression Clinic
New York, New York, United States, 10032
4
UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
Pittsburgh, Pennsylvania, United States, 15213