Late Life Treatment Resistant DepressionPhase 2BAARDNCT07810738
The BAARD Study : Evaluating a Computerized Approach to Treatment Selection in Older Adults With Treatment Resistant Depression.
A Phase 2 study testing Aripiprazole Augmentation and Bupropion Augmentation in people with Late Life Treatment Resistant Depression and Depression - Major Depressive Disorder, run by Washington University School of Medicine at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Late Life Treatment Resistant Depression, Depression - Major Depressive Disorder, Treatment Resistant Depression
- What is being tested?
- Aripiprazole Augmentation and Bupropion Augmentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Oct 2026to 15 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites
UPMC Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213
Marie Anne Gebara, MD, 412-246-6024, gebarama@upmc.edu
Joelle M Kincman, PhD, 412-246-6012, scanjm2@upmc.edu
Washington University School of Medicine
St Louis, Missouri, 63110
Canada1 site
Center for addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H1
Daniel Felsky, PhD, 416-583-1350, Daniel.Felsky@camh.ca
Benoit Mulsant, MD, 416-583-1350, BAARDstudy@camh.ca
About this study
Official title: Biotype-assigned Augmentation Approach in Resistant Late-Life Depression (BAARD): a Randomized Controlled Trial
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:
Read more
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
- Being tested
- Aripiprazole Augmentation, Bupropion Augmentation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole AugmentationDrug
Also called Aripiprazole
Aripiprazole augmentation will be started at 2 mg and increased based on symptoms and tolerability up to a maximum dose of 15 mg.
Bupropion AugmentationDrug
Also called Bupropion
Bupropion augmentation will be started at 150 mg and increased based on symptoms and tolerability up to a maximum dose of 450 mg.
| Study group | Role | What they receive |
|---|---|---|
| BAARD-assigned | Experimental | The BAARD predictive model will use individual participants' data to advise which of two treatments to select, aripiprazole or bupropion. Receives: 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. Receives: Drug: Aripiprazole Augmentation; Drug: Bupropion Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Mar 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ginger E Nicol, Washington University School of Medicine
- Investigators
- Ginger E Nicol, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810738
- Sponsor's protocol ID
- 202603103
- Other IDs
- 1UG3MH137353-01
- Acronym
- BAARD
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biotype-assigned Augmentation Approach in Resistant Late-Life Depression (BAARD): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07810738
- Acronym / sponsor ID
- BAARD / 202603103
- Conditions
- Late Life Treatment Resistant Depression, Depression - Major Depressive Disorder, Treatment Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAARD-assigned | Experimental | Drug: Aripiprazole Augmentation, Drug: Bupropion AugmentationThe BAARD predictive model will use individual participants' data to advise which of two treatments to select, aripiprazole or bupropion. |
| Randomly assigned | Active comparator | Drug: Aripiprazole Augmentation, Drug: Bupropion AugmentationThe randomly assigned arm will randomly assign one of two treatments to select, aripiprazole or bupropion. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 years and older
- Diagnosis of treatment resistant depression, as verified by:
- Ability to provide informed consent and complete the study assessments Taking antidepressant at adequate dose for at least 4 weeks
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole AugmentationAlso: AripiprazoleAripiprazole augmentation will be started at 2 mg and increased based on symptoms and tolerability up to a maximum dose of 15 mg. | Drug | BAARD-assigned, Randomly assigned |
| Bupropion AugmentationAlso: BupropionBupropion augmentation will be started at 150 mg and increased based on symptoms and tolerability up to a maximum dose of 450 mg. | Drug | BAARD-assigned, Randomly assigned |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Late Life Treatment Resistant Depression
Recruiting
Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression
Late Life Depression (LLD), Depression - Major Depressive Disorder
RecruitingPhase 3
Lumateperone for Late-Life Depression
Treatment Resistant Depression (TRD), Late Life Depression (LLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ginger E Nicol principal investigator
Washington University School of Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aripiprazole Augmentation and Bupropion Augmentation in people with Late Life Treatment Resistant Depression and Depression - Major Depressive Disorder, run by Washington University School of Medicine at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ginger E Nicol, MD (314-747-1862, nicolg@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission from Depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS) score ≤10 (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.