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NCT Number: NCT07810738

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Aripiprazole

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.

Other names: Bupropion

Primary outcomes

  1. Remission from Depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS) score ≤10

    Time frame: Week 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ginger E Nicol, MD

CONTACT

[email protected]

314-747-1862

Teddi L Gray

CONTACT

[email protected]

3147471862

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Biotype-assigned Augmentation Approach in Resistant Late-Life Depression (BAARD): a Randomized Controlled Trial

Acronym: BAARD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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