Longitudinal Observational Biomarker Study (NCT05204940) | Clinical Trial Compass
CompletedNot Applicable
Longitudinal Observational Biomarker Study
United States, Canada506 participantsStarted 2017-09-27
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Persistent Depression Leading to Change in Cognition