The BAARD Study : Evaluating a Computerized Approach to Treatment Selection in Older Adults With Treatment Resistant Depression.
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT07810738
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Depression - Major Depressive Disorder
- Late Life Treatment Resistant Depression
- Treatment Resistant Depression
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- First listed
- Sep 9, 2026
- Start date
- Oct 1, 2026
- Status verified
- Sep 2026
- Primary completion
- Mar 15, 2029
- Completion
- Sep 15, 2029
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: BAARD-assignedThe BAARD predictive model will use individual participants' data to advise which of two treatments to select, aripiprazole or bupropion.
- Active Comparator: Randomly assignedThe randomly assigned arm will randomly assign one of two treatments to select, aripiprazole or bupropion.
Primary Outcome Measure
Remission from Depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS) score ≤10 [ Time Frame: Week 10 ]
Central Contacts
- Ginger E Nicol, MD314-747-1862
- Teddi L Gray3147471862
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | - |
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