DepressionOPT-NeuroNCT05204940
Longitudinal Observational Biomarker Study
An observational study of Depression and Dementia, run by Centre for Addiction and Mental Health at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Dementia, Mild Cognitive Impairment
- What is being tested?
- Mechanisms of Late life depression (LLD)-dementia through functional Magnetic Resonance Imaging (fMRI), Neuropsychological Data and Clinical Scales
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 506 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 27 Sep 2017to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Seizure disorder.
- Parkinson's Disease
- Individuals with any contraindications to MRI
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
UCLA Late-Life Mood, Stress, and Wellness Research Program
Los Angeles, California, 90095
Columbia University Adult and Late Life Depression Clinic
New York, New York, 10032
UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
Pittsburgh, Pennsylvania, 15213
Washington University School of Medicine Healthy Mind Lab
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Dementia, Mild Cognitive Impairment
- Being tested
- Mechanisms of Late life depression (LLD)-dementia through functional Magnetic Resonance Imaging (fMRI), Neuropsychological Data, Clinical Scales
- Medical subject headings
- Depression, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanisms of Late life depression (LLD)-dementia through functional Magnetic Resonance Imaging (fMRI)Behavioural
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 DataBehavioural
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 ScalesBehavioural
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6-months, 24-months
Secondary outcomes (1)
Change in Neural Circuity
To test whether greater degradation of neural circuitry is associated with greater cognitive decline
Measured: Baseline, 6-months, 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start27 Sep 2017
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Aristotle Voineskos, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204940
- Sponsor's protocol ID
- 080/2017
- Other IDs
- R01MH114970, R01MH114980, R01MH114969, R01MH114981, R01MH114966-01
- Acronym
- OPT-Neuro
- Status last verified
- Nov 2024
- First submitted
- 24 Dec 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro Study)
- ClinicalTrials.gov ID
- NCT05204940
- Acronym / sponsor ID
- OPT-Neuro / 080/2017
- Conditions
- Depression, Dementia, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Patient-Centered Outcomes Research Institute
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | – |
| Neuropsychological DataNeuropsychological 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). | Behavioural | – |
| Clinical ScalesClinical 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). | Behavioural | – |
Primary outcome
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
1 secondary outcome
Change in Neural Circuity
Time frame: Baseline, 6-months, 24-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aristotle Voineskos, MD principal investigator
Centre for Addiction and Mental Health
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Dementia, run by Centre for Addiction and Mental Health at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Depression Leading to Change in Cognition (time frame: Baseline, 6-months, 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.