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Aripiprazole + Bupropion for Depression

(BAARD Trial)

GE
TL
Overseen ByTeddi L Gray
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this 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:

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.

Who Is on the Research Team?

GE

Ginger E Nicol

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for older adults who have depression that hasn't improved with standard treatments. Participants should already be taking medication for depression and be willing to add another medicine as part of the study.

Inclusion Criteria

I have been taking an antidepressant at the right dose for at least 4 weeks.
I am 60 years old or older.
I have treatment-resistant depression with a PHQ-9 score of 10 or higher.
See 1 more

Exclusion Criteria

High risk for suicide defined as 4 or 5 on C-SSRS indicating active suicidal ideation with intent or plan and unable to be managed safely in trial
Dementia defined by Short Blessed Test score of at least 10 and/or documented diagnosis of dementia
Lifetime diagnosis of DSM-5 Bipolar I or II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, current psychotic symptoms, or current (within 3 months) moderate to severe alcohol or substance use disorder diagnosed by SCID
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Aripiprazole
  • Bupropion

Trial Overview

The study compares two ways of choosing an extra medication—either using a computer model (BAARD) or random selection—to see which helps improve depression symptoms more. The added medications are aripiprazole or bupropion, taken alongside current treatment for 10 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BAARD-assignedExperimental Treatment2 Interventions
Group II: Randomly assignedActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

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