The BAARD Study : Evaluating a Computerized Approach to Treatment Selection in Older Adults With Treatment Resistant Depression.

NCT07810738 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2026031031UG3MH137353-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Late Life Treatment Resistant Depression; Depression - Major Depressive Disorder; Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 10

Study Arms (2)

BAARD-assigned

EXPERIMENTAL

The BAARD predictive model will use individual participants' data to advise which of two treatments to select, aripiprazole or bupropion.

Drug: Aripiprazole Augmentation; Drug: Bupropion Augmentation

Randomly assigned

ACTIVE COMPARATOR

The randomly assigned arm will randomly assign one of two treatments to select, aripiprazole or bupropion.

Drug: Aripiprazole Augmentation; Drug: Bupropion Augmentation

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.

Also known as: Aripiprazole

BAARD-assigned; Randomly assigned

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.

Also known as: Bupropion

BAARD-assigned; Randomly assigned

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years and older
• Diagnosis of treatment resistant depression, as verified by:
• 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
• Ability to provide informed consent and complete the study assessments Taking antidepressant at adequate dose for at least 4 weeks

You may not qualify if:

• 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.
• Physical conditions that, in the estimation of the study physician, prevent safe participation or suggest a high probability of death, or unstable medical illnesses that are not under medical management.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Aripiprazole; Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Ginger E Nicol

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ginger E Nicol, MD

CONTACT

314-747-1862; nicolg@wustl.edu

Teddi L Gray

CONTACT

3147471862; grayt@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): September 15, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)