Aripiprazole + Bupropion for Depression

(BAARD Trial)

Not yet recruiting at 2 trial locations
GE
TL
Overseen ByTeddi L Gray
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
Must be taking: Antidepressants
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?

This trial tests new methods for selecting medications for older adults with depression unresponsive to standard treatments. It aims to determine if a predictive model, called BAARD, can more effectively reduce depression symptoms compared to random selection. Participants will take either aripiprazole (an antipsychotic) or bupropion (an antidepressant) alongside their current antidepressant for 10 weeks. Individuals aged 60 and over, who have tried at least two antidepressants without success, may qualify for this study. Regular follow-ups will monitor progress and ensure safety. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from a more targeted approach to depression treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both aripiprazole and bupropion are generally safe and effective for treating depression. Aripiprazole, often used for depression and other mood disorders, has undergone extensive study. While most people find it safe, some may experience side effects like weight gain or restlessness.

Bupropion is another medication commonly used for depression, known for causing fewer sexual side effects compared to some other antidepressants. However, it can cause trouble sleeping or a dry mouth in some individuals. Both medications have FDA approval for treating depression and other conditions, indicating a good safety record when used as directed.

Prospective trial participants should consult a healthcare provider for advice tailored to their personal health needs.12345

Why are researchers excited about this trial?

Researchers are excited about the trial of aripiprazole and bupropion for depression because it uses a smart, tailored approach to treatment selection. Unlike standard treatments that often involve trial and error with medications like SSRIs or SNRIs, this trial employs the BAARD predictive model to analyze individual data and suggest the best medication, whether aripiprazole or bupropion, for each participant. This personalized method could lead to faster, more effective relief for patients by matching them with the most suitable treatment from the start, rather than relying on random assignment or traditional methods.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that both aripiprazole and bupropion can aid individuals with depression unresponsive to other treatments. In this trial, participants will receive either aripiprazole or bupropion. Specifically, adding aripiprazole to regular antidepressants has helped older adults by balancing dopamine, which can enhance mood. Many studies have proven that bupropion lowers depression levels, functioning like other antidepressants but often with fewer side effects. Both medications have strong evidence supporting their ability to improve depression symptoms, making them promising options for those who haven't found relief from other treatments.678910

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Aripiprazole or Bupropion in addition to their current medication

10 weeks
Weekly or bi-weekly follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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+

Citations

Adjunctive Aripiprazole for MDD

Aripiprazole augmentation may be an effective long-term strategy for treatment of refractory depression. · Lower maintenance doses (< 5 mg) of ...

Augmentation treatment in major depressive disorder - PMC

In particular, aripiprazole has shown efficacy as an augmentation option with standard antidepressant therapy in two, large, randomized, double-blind studies.

a randomised, double-blind, placebo-controlled trial

In conclusion, our results showed that aripiprazole is moderately effective in older adults with treatment-resistant depression. Clinicians prescribing this ...

View of Aripiprazole

The objective of the Clinical Review is to review and critically appraise the evidence on the beneficial and harmful effects of aripiprazole 2 mg to 15 mg per ...

Efficacy and safety of aripiprazole or bupropion augmentation ...

It has the effect of stabilizing dopamine and can eliminate adverse emotions such as depression. Analysis of severe events found no significant ...

Depression (major depressive disorder) - Symptoms and ...

Antenatal use of antidepressants and the potential risk of teratogenicity and adverse pregnancy outcomes: Selective serotonin reuptake ...

Depression - National Institute of Mental Health (NIMH)

Learn about NIMH research on depression. Find resources on the signs and symptoms of depression, types, and potential treatments and therapies.

Depression

Depression requires active treatment, because the disorder can have enduring effects on brain function that make future episodes more likely.

Depression: What It Is, Symptoms, Types & Treatment

And it can lead to serious complications, like suicidal thoughts and behavior. About 3 in 10 adults receive this diagnosis at some point in ...

Depressive disorder (depression)

WHO fact sheet on depression, providing information on prevalence, symptoms, prevention and contributing factors, diagnosis and treatment, ...