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 — DRUG
    Aripiprazole augmentation will be started at 2 mg and increased based on symptoms and tolerability up to a maximum dose of 15 mg.
  • Bupropion Augmentation — DRUG
    Bupropion 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-assigned
    The BAARD predictive model will use individual participants' data to advise which of two treatments to select, aripiprazole or bupropion.
  • Active Comparator: Randomly assigned
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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