ClinicalTrials.gg
Not yet recruitingNCT07810738BAARDUpdated Nov 13, 2026

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

A Phase 2 interventional study of Aripiprazole Augmentation and Bupropion Augmentation in Late Life Treatment Resistant Depression, Depression - Major Depressive Disorder and Treatment Resistant Depression, sponsored by Washington University School of Medicine. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment

Updated Nov 13, 2026First site in CanadaStart date moved+1 moreGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Depressive Disorder, Treatment-Resistant by Washington University School of Medicine — 3 open to participants now, 5 under way, none of them phase 3. Depressive Disorder, Treatment-Resistant · Washington University School of Medicine.

Planned enrollment
2nd of 11
300 · median 25
Started
2026
the only one that year
Phase 2
3 of 12
1 open now
Registered
12th of 12
by date

Among the 12 studies in Depressive Disorder, Treatment-Resistant by Washington University School of Medicine, this one is the 2nd largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 3 in phase 2, and was the 12th registered.

Depressive Disorder, Treatment-Resistant

448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.

Browse Depressive Disorder, Treatment-Resistant studies →

Open to participants now

3 of the 12 studies in Depressive Disorder, Treatment-Resistant by Washington University School of Medicine are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 114 Depressive Disorder, Treatment-Resistant studies recruiting now, 26 (23%) set no upper age limit and 76 (67%) stop at 75 or younger; 1 takes children under 18; 13 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Late Life Treatment Resistant Depression
  • Depression - Major Depressive Disorder
  • Treatment Resistant Depression
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 60 years and older
  2. Diagnosis of treatment resistant depression, as verified by:

    1. Diagnosis of Major Depressive Disorder according to Structured Clinical Interview for DSM-5 Disorders (SCID) AND
    2. Baseline score of at least 10 on the 9-item Patient Health Questionnaire (PHQ-9) AND
    3. 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
  3. Ability to provide and complete the study assessments Taking antidepressant at adequate dose for at least 4 weeks

Exclusion criteria

Exclusion Criteria:

  1. Dementia, as defined by Short Blessed Test score at least10 and/or documented diagnosis of dementia.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    BAARD-assigned

    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

  • Active comparator
    Randomly assigned

    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 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

  • 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

06

What researchers measure

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.

    Time frame: Week 10

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2029, 28 months later.

Of 50 phase 2 interventional studies under Depressive Disorder, Treatment-Resistant, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 41. This study's planned 28 months is close to that.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 13, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 9, 2026
StartEst.
Nov 1, 2026was Oct 2026
Primary completionEst.
Mar 15, 2029
CompletionEst.
Sep 15, 2029
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added — first site in Canada
Show 2 added (1 United States, 1 Canada)
  • UPMC Western Psychiatric Hospital · Pittsburgh, United States
  • Center for addiction and Mental Health (CAMH) · Toronto, Canada
Oct 16, 2026
Start date
Oct 1, 2026→Nov 1, 2026
Nov 13, 2026
Show all 2 updates
  1. Nov 13, 2026
    Start date Oct 1, 2026→Nov 1, 2026
    + 1 other change: site details
  2. Oct 16, 2026
    2 sites added — first site in Canada
    Show 2 added (1 United States, 1 Canada)
    • UPMC Western Psychiatric Hospital · Pittsburgh, United States
    • Center for addiction and Mental Health (CAMH) · Toronto, Canada

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07810738
Responsible party
Ginger E Nicol (Professor of Psychiatry, Washington University School of Medicine) — Principal investigator
First posted
Sep 9, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Mar 15, 2029 (estimated)
Completion
Sep 15, 2029 (estimated)
Last update
Nov 13, 2026

Study contacts

Ginger E Nicol, MD
Contact
nicolg@wustl.edu
314-747-1862
Teddi L Gray
Contact
grayt@wustl.edu
3147471862
Ginger E Nicol
principal investigator · Washington University School of Medicine

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Aripiprazole · Bupropion

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