RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT) (ONR)
Depression, Dementia, Mild Cognitive Impairment
About this trial
This is an interventional treatment trial for Depression focused on measuring Comparative Effectiveness Research, Pragmatic Clinical Trials, Patient-Centered Outcomes Research, Research Clinical Trial, RCT
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- UCLA Late-Life Mood, Stress, and Wellness Research Program
- Washington University School of Medicine Healthy Mind Lab
- Columbia University Adult and Late Life Depression Clinic
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Aripiprazole Augmentation
Bupropion Augmentation
Switch to Bupropion
Lithium Augmentation
Switch to Nortriptyline
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
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).
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.