The goal of this clinical trial is to test whether a personalized approach to treatment selection improves symptoms in older adults with treatment-resistant depression.
The main questions it aims to answer is:
Will using the BAARD predictive models to select medications lead to better depression outcomes, compared to randomly selecting medications?
Researchers will use the BAARD predictive models or random assignment to choose one of two medications to add to patients' current treatment. Patients will be asked to take either aripiprazole or bupropion along with their current medication.
Participants will:
Take Aripiprazole or Bupropion in addition to their current medication for 10 weeks.
Complete follow-up assessments every 1-2 weeks for checkups.
Age 60 years and older
Diagnosis of DSM-5 Major Depressive Disorder according to Structured Clinical Interview for DSM-5 Disorders (SCID) AND
Baseline score of at least 10 on the 9-item Patient Health Questionnaire (PHQ-9) AND
Either i. At least 2 prior antidepressant trials in the current episode of adequate dose and duration as determined with the Antidepressant Treatment History Form (ATHF), OR ii. one failed trial of a serotonin norepinephrine reuptake inhibitor (SNRI) of adequate dose and duration, including the current antidepressant, OR iii. failed at least 1 antidepressant trial of adequate dose and duration as determined with the ATHF in a prior episode and present in relapse while on another antidepressant of adequate dose and duration as determined with ATHF
Dementia, as defined by Short Blessed Test score at least10 and/or documented diagnosis of dementia.
Lifetime diagnosis of DSM 5 Bipolar I or II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, or current psychotic symptoms, or current (within 3 months) moderate to severe alcohol or substance use disorder as diagnosed by the SCID.
High risk for suicide, defined as a 4 or 5 on C-SSRS46 (indicating active suicidal ideation with current or recent intent or plan), and unable to be managed safely in the clinical trial. Urgent psychiatric referral will be made in these cases.
Contraindication to study medications (aripiprazole or bupropion XL), as determined by study physician, including history of intolerance or non-response to bupropion (or equivalent bupropion containing drug) as an augmentation agent at greater than or equal to 300 mg or aripiprazole as an augmentation agent at greater than or equal to 5 mg.
Parallel
Aripiprazole Augmentation
DrugAripiprazole augmentation will be started at 2 mg and increased based on symptoms and tolerability up to a maximum dose of 15 mg.
Bupropion Augmentation
DrugBupropion augmentation will be started at 150 mg and increased based on symptoms and tolerability up to a maximum dose of 450 mg.
Remission from Depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS) score ≤10
The MADRS is a 10-item instrument used to assess depression severity. In this trial the MADRS will be used to assess remission of depression, defined as a MADRS score ≤10. The total MADRS score ranges from 0-60, with higher scores indicating increased severity of depression.
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
