Clinical trial NCT05204940: Longitudinal Observational Biomarker Study
Official title: Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Dementia
Mild Cognitive Impairment
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Patient-Centered Outcomes Research Institute
First posted: 2022-01-24
Enrollment: 506
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit 750 patient across all 5 sites who are 60 years or older with Major Depressive Disorder. All participants will be recruited from the OPTIMUM trial (clinicaltrials.gov identifier NCT02960763); all participants who consent and are eligible to participate in OPTIMUM will be invited to participate in this neuroimaging/neurocognitive study. Eligibility bellow will be determined and assessed as per the OPTIMUM clinical trial. In addition, they will have no contra-indications for MRI scanning.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Persistent Depression Leading to Change in Cognition
timeFrame: Baseline, 6-months, 24-months
Secondary outcomes:
measure: Change in Neural Circuity
timeFrame: Baseline, 6-months, 24-months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Late-Life Mood, Stress, and Wellness Research Program
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine Healthy Mind Lab
state: Missouri
city: New York
country: United States
facility: Columbia University Adult and Late Life Depression Clinic
state: New York
city: Pittsburgh
country: United States
facility: UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
state: Pennsylvania
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Aristotle Voineskos, MD
role: PRINCIPAL_INVESTIGATOR
References: