DepressionPhase 4ONRNCT05531591
RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT)
A Phase 4 study testing Aripiprazole Augmentation, Bupropion Augmentation and Switch to bupropion in people with Depression and Dementia, run by Centre for Addiction and Mental Health at 4 sites in 2 countries.
Trial summary
The purpose of this study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD), and 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?
- Aripiprazole Augmentation, Bupropion Augmentation and Switch to bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Aug 2019to 31 Jul 2024
- Phase
- Phase 4
- 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
Who may be able to join
- Men and women aged 60 and older, with approximately equal proportions aged 60-70 and 70+.
- Current Major Depressive Disorder (MDD), single or recurrent, as diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (approximately 12 weeks).
- PHQ-9 score of 10 or higher.
Who cannot join
- Dementia; patients screened out due to possible dementia will be referred to a local Memory Clinic or back to their clinician for evaluation to clarify the presence or absence of dementia.
- Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
- High risk for suicide (e.g. active Suicidal ideations (SI) and or current/recent intent or plan)). Urgent psychiatric referral will be made in these cases.
- Non-correctable, clinically significant sensory impairment (e.g., cannot hear well enough to cooperate with interview).
- 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, as determined by study physician.
- Seizure disorder.
- Parkinson's Disease
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 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
Washington University School of Medicine Healthy Mind Lab
St Louis, Missouri, 63110
About this study
Official title: RCT of Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro RCT)
The purpose of this study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD), and 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
Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy.
- Adding aripiprazole to current antidepressant medication
- Adding bupropion to current antideprssant medication
- Replacing current antidepressant medication with bupropion
If depression is not relieved at the end of 10 weeks, or if participants do not qualify for Step 1, participants will be randomly assigned to a Step 2 medication strategy:
- Adding lithium to current antidepressant medication
- Replacing current antidepressant medication with nortriptyline
All medication strategies will be offered in collaboration with participants' own physicians with the the research team providing support and guidance.
After treatment in Step 1 and/or Step 2, participants will enter the Continuation Phase to assess long term follow-up outcomes for 12 months.
Participants in the Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM) (NCT02960763) study, will also be asked to participate in this clinical trial to gather imaging and biomarker data. The study will 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 will be collecting blood biomarkers as part of their study procedures. These samples will be used to look at other factors that may relate to depression or memory and attention processes.
- 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.
- 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 Scales: Including the Everyday Cognition Scale (E-Cog), Global Clinical Dementia Rating (CDR), Performance Assessment of Selfcare Skills (PASS)-Cognitive Instrumental Activities of Daily Living(CIADL) 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).
Investigators hope that this 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, Treatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression
- Being tested
- Aripiprazole Augmentation, Bupropion Augmentation, Switch to bupropion, Lithium Augmentation, Switch to nortriptyline
- Keywords
- Comparative Effectiveness Research, Pragmatic Clinical Trials, Patient-Centered Outcomes Research, Research Clinical Trial, RCT
- Medical subject headings
- Depression, Dementia, Cognitive Dysfunction, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole AugmentationDrug
Also called Abilify
Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
Bupropion AugmentationDrug
Also called Wellbutrin
Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
Switch to bupropionDrug
Also called Wellbutrin
Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
Lithium AugmentationDrug
Also called Lithium carbonate, Eskalith
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Switch to nortriptylineDrug
Also called Pamelor
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole Augmentation | Experimental | Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects. Receives: Drug: Aripiprazole Augmentation |
| Bupropion Augmentation | Experimental | Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects. Receives: Drug: Bupropion Augmentation |
| Switch to Bupropion | Experimental | Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects. Receives: Drug: Switch to bupropion |
| Lithium Augmentation | Experimental | Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 mEq/L (milliequivalents/liter). Receives: Drug: Lithium Augmentation |
| Switch to Nortriptyline | Experimental | Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. Receives: Drug: Switch to nortriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Well-Being
Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, Standard Deviation (SD)=10.
Measured: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Assessing the change in the Number of Participants With Remission From Depression
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.
Measured: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Safety Outcomes Assessment for Serious Adverse Events
Assessing; Life threatening illness, hospitalization, or need of medical care over the duration of the study
Measured: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
To observe whether persistent (non-remitting) depression leads to greater cognitive decline (focusing on executive and episodic memory (EEM)-related cognitive domains
Using baseline differences to compare if non-remitters demonstrate greater decline in EEM than remitters leading to greater cognitive decline using . Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
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 posted8 Sep 2022
- Study start1 Aug 2019
- 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.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 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)
- Responsible party
- Sponsor
- Investigators
- Aristotle Voineskos, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531591
- Sponsor's protocol ID
- 080-2017, 086-2016 RCT
- Other IDs
- R01MH114970, R01MH114980, R01MH114981, R01MH114966-01
- Acronym
- ONR
- Status last verified
- Nov 2024
- First submitted
- 19 Aug 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- 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
- RCT of Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro RCT)
- ClinicalTrials.gov ID
- NCT05531591
- Acronym / sponsor ID
- ONR / 080-2017, 086-2016 RCT
- Conditions
- Depression, Dementia, Mild Cognitive Impairment, Treatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression
- Keywords
- Comparative Effectiveness Research, Pragmatic Clinical Trials, Patient-Centered Outcomes Research, Research Clinical Trial, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 Sep 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 assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD), and to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function.
Detailed description
Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy.
- Adding aripiprazole to current antidepressant medication
- Adding bupropion to current antideprssant medication
- Replacing current antidepressant medication with bupropion
If depression is not relieved at the end of 10 weeks, or if participants do not qualify for Step 1, participants will be randomly assigned to a Step 2 medication strategy:
- Adding lithium to current antidepressant medication
- Replacing current antidepressant medication with nortriptyline
All medication strategies will be offered in collaboration with participants' own physicians with the the research team providing support and guidance.
After treatment in Step 1 and/or Step 2, participants will enter the Continuation Phase to assess long term follow-up outcomes for 12 months.
Participants in the Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM) (NCT02960763) study, will also be asked to participate in this clinical trial to gather imaging and biomarker data. The study will 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 will be collecting blood biomarkers as part of their study procedures. These samples will be used to look at other factors that may relate to depression or memory and attention processes.
- 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.
- 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 Scales: Including the Everyday Cognition Scale (E-Cog), Global Clinical Dementia Rating (CDR), Performance Assessment of Selfcare Skills (PASS)-Cognitive Instrumental Activities of Daily Living(CIADL) 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).
Investigators hope that this 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole Augmentation | Experimental | Drug: Aripiprazole AugmentationAugment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects. |
| Bupropion Augmentation | Experimental | Drug: Bupropion AugmentationAugment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects. |
| Switch to Bupropion | Experimental | Drug: Switch to bupropionTaper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects. |
| Lithium Augmentation | Experimental | Drug: Lithium AugmentationAugment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 mEq/L (milliequivalents/liter). |
| Switch to Nortriptyline | Experimental | Drug: Switch to nortriptylineTaper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 60 and older, with approximately equal proportions aged 60-70 and 70+.
- Current Major Depressive Disorder (MDD), single or recurrent, as diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (approximately 12 weeks).
- PHQ-9 score of 10 or higher.
Key exclusion criteria (8 listed)
- Dementia; patients screened out due to possible dementia will be referred to a local Memory Clinic or back to their clinician for evaluation to clarify the presence or absence of dementia.
- Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
- High risk for suicide (e.g. active Suicidal ideations (SI) and or current/recent intent or plan)). Urgent psychiatric referral will be made in these cases.
- Non-correctable, clinically significant sensory impairment (e.g., cannot hear well enough to cooperate with interview).
- 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 |
|---|---|---|
| Aripiprazole AugmentationAlso: AbilifyAugment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects. | Drug | Aripiprazole Augmentation |
| Bupropion AugmentationAlso: WellbutrinAugment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. | Drug | Bupropion Augmentation |
| Switch to bupropionAlso: WellbutrinTaper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects. | Drug | Switch to Bupropion |
| Lithium AugmentationAlso: Lithium carbonate, EskalithAugment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. | Drug | Lithium Augmentation |
| Switch to nortriptylineAlso: PamelorTaper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml | Drug | Switch to Nortriptyline |
Primary outcome
Change in Psychological Well-Being
Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, Standard Deviation (SD)=10.
Assessing the change in the Number of Participants With Remission From Depression
Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.
Safety Outcomes Assessment for Serious Adverse Events
Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Assessing; Life threatening illness, hospitalization, or need of medical care over the duration of the study
To observe whether persistent (non-remitting) depression leads to greater cognitive decline (focusing on executive and episodic memory (EEM)-related cognitive domains
Time frame: Baseline, 6-months, 24-months
Using baseline differences to compare if non-remitters demonstrate greater decline in EEM than remitters leading to greater cognitive decline using . Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole Augmentation, Bupropion Augmentation and Switch to bupropion in people with Depression and Dementia, run by Centre for Addiction and Mental Health at 4 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 8 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 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Psychological Well-Being (time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks). The study lists 4 primary outcomes in all. 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.