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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: Take Aripiprazole or Bupropion in addition to their current medication for 10 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults age 60 and older whose depression has not improved with treatment. It tests whether a computer-based tool can choose an added medicine better than choosing by chance. Participants take aripiprazole or bupropion with their current medicine for 10 weeks and have checkups every 1–2 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 60 or older.
  • A study interview confirms that you have major depression.
  • You score at least 10 on the PHQ-9, a questionnaire about depression symptoms.
  • Past depression medicines have not worked well enough despite the right dose and enough time. You must meet one of these patterns: two medicine trials during your current depression episode; one trial of an SNRI, a type of antidepressant; or a failed trial in an earlier episode, with depression returning while taking another antidepressant.
  • You have taken your current antidepressant at the right dose for at least 4 weeks.
  • You can agree to join after learning about the study and can complete the study checkups.

Who can't join

  • You have a recorded diagnosis of dementia, which affects memory and thinking, or score at least 10 on the Short Blessed Test.
  • You have ever been diagnosed with bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder. These conditions affect mood or how you understand what is real.
  • You currently have symptoms of psychosis, such as seeing or hearing things that are not there.
  • You have had a moderate to severe alcohol or drug use disorder within the past 3 months.
  • You have a high suicide risk with current or recent intent or a plan, and the study team cannot keep you safe in the trial. The team will arrange urgent mental health care.
  • The study doctor says aripiprazole or bupropion XL is not safe or suitable for you. This includes past side effects you could not tolerate or lack of benefit when added to treatment at doses of at least 300 mg of bupropion or 5 mg of aripiprazole.
  • The study doctor believes a physical illness makes joining unsafe or makes death highly likely, or you have an unstable illness that is not being medically managed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age 60 years and older 2. Diagnosis of treatment resistant depression, as verified by: 1. Diagnosis of DSM-5 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 informed consent and complete the study assessments Taking antidepressant at adequate dose for at least 4 weeks 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. 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. 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.

Study sites (2)

MO

PA