- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05204940
Longitudinal Observational Biomarker Study (OPT-Neuro)
October 19, 2023 updated by: Centre for Addiction and Mental Health
Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro Study)
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.
Study Overview
Status
Active, not recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
750
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M6J 1H1
- Centre for Addiction and Mental Health
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-
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California
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Los Angeles, California, United States, 90095
- UCLA Late-Life Mood, Stress, and Wellness Research Program
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine Healthy Mind Lab
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New York
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New York, New York, United States, 10032
- Columbia University Adult and Late Life Depression Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Persistent Depression Leading to Change in Cognition
Time Frame: Baseline, 6-months, 24-months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Neural Circuity
Time Frame: Baseline, 6-months, 24-months
|
To test whether greater degradation of neural circuitry is associated with greater cognitive decline
|
Baseline, 6-months, 24-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Aristotle Voineskos, MD, Centre for Addiction and Mental Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2017
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
December 24, 2021
First Submitted That Met QC Criteria
January 21, 2022
First Posted (Actual)
January 24, 2022
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080/2017
- R01MH114970 (U.S. NIH Grant/Contract)
- R01MH114980 (U.S. NIH Grant/Contract)
- R01MH114981 (U.S. NIH Grant/Contract)
- R01MH114966-01 (U.S. NIH Grant/Contract)
- R01MH114969 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available on the National Institute of Mental Health (NIMH) Data Archive and registered at clinicaltrials.gov.
IPD Sharing Time Frame
Data will become available after all analyses and initial publication is complete.
IPD Sharing Access Criteria
The data will be accessible through the NIMH Data Archive (Collection ID: 2851).
Please contact the principal investigators if you have further queries about access criteria.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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