Effort-based Decision-Making Task for Depression

(BBQS Trial)

Overseen By Sankaraleengam Alagapan, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia Institute of Technology

Must not be taking: Antipsychotics

Disqualifiers: Psychotic symptoms, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are currently on antipsychotics.

How does the Effort-based Decision-Making Task for Depression treatment differ from other treatments for depression?

This treatment is unique because it focuses on improving effort-based decision-making, which is often impaired in depression. Unlike traditional treatments that primarily target mood symptoms, this approach aims to enhance motivation and the ability to make decisions involving effort, potentially addressing core deficits in depression. ^{1 2 3 4 5}

What is the purpose of this trial?

Major depressive disorder (MDD) is a serious condition that causes long-term symptoms such as feeling sad, losing interest in activities, and having thoughts of self-harm. Difficulty in making an effort is a key factor in functional impairment. Current methods to evaluate this difficulty use clinical assessments and computer-based tasks, but there is a gap between the measurements and real-life behavior. To address this, the study team proposes creating an instrumented behavioral test, HORMES, to objectively assess reduced motivation during everyday activities and measure physiological responses. The study will examine differences in brain activity, autonomic system function, and metabolic energy expenditure in patients with major depression during a decision-making task that involves physical effort.

Research Team

Christopher J Rozell, Ph.D.

Principal Investigator

Georgia Institute of Technology

Eligibility Criteria

This trial is for individuals with major depressive disorder (MDD), particularly those who experience anhedonia or a lack of pleasure in daily activities. Participants should have difficulty making efforts, which affects their day-to-day functioning.

Inclusion Criteria

I am 18-65, diagnosed with major depression, and understand the study's risks and benefits.

Exclusion Criteria

I do not have a psychiatric disorder, am not pregnant, my BMI is 35 or less, and I am not taking antipsychotics.

I have depression but no psychosis, other mental disorders, am not pregnant, my BMI is 35 or less, and I'm not on antipsychotics.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Effort-based decision-making task

Participants perform a virtual-reality-based task in which they expend effort to receive virtual rewards. The task involves walking on a treadmill with varying inclines to measure physiological responses and effort-based decision-making.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the task, with a focus on physiological and behavioral outcomes.

4 weeks

Treatment Details

Interventions

• Effort-based Decision-Making Task

Trial Overview The study is testing a new behavioral test called HORMES designed to objectively assess motivation and effort during everyday tasks. It will measure brain activity, autonomic system function, and energy use while participants complete a decision-making task that requires physical effort.

Participant Groups

Group I: Effort-based decision-making Experimental Treatment 1 Intervention

Participants perform a virtual-reality-based task in which they expend effort to receive virtual rewards.

Who Is Running the Clinical Trial?

Georgia Institute of Technology

Lead Sponsor

Trials

53

Recruited

5,600+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Why don't you try harder? An investigation of effort production in major depression. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Attentional resources in major depression. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Modeling Effort-Based Decision Making: Individual Differences in Schizophrenia and Major Depressive Disorder. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Bupropion increases selection of high effort activity in rats tested on a progressive ratio/chow feeding choice procedure: implications for treatment of effort-related motivational symptoms. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive effort-based decision-making in major depressive disorder. [2023]