A Phase 4 interventional study of Aripiprazole Augmentation and Bupropion Augmentation in Depression, Dementia and Mild Cognitive Impairment, sponsored by Centre for Addiction and Mental Health. Completed at 4 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Centre for Addiction and Mental Health · Phase 4, Interventional, and Treatment
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.
Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy.
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:
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 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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 87 is close to the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Drug: Aripiprazole Augmentation
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Drug: Bupropion Augmentation
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Drug: Switch to bupropion
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).
Drug: Lithium Augmentation
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.
Drug: Switch to nortriptyline
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.
Also known as: Abilify
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.
Also known as: 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.
Also known as: Wellbutrin
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Also known as: Lithium carbonate, Eskalith
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
Also known as: Pamelor
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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Baseline, 6-months, 24-months
Plasma biomarkers will be analyzed using a customized multiplex protein array platform for the Senescence-Associated Secretory Phenotype (SASP).
The SASP index will be used to look at circulating proteins related to immune-inflammatory control
Time frame: Baseline, 6-months, 24-months
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health