NCT05537584

SMART Trial to Predict Anhedonia Response to Antidepressant Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this research is to use behavioral, brain, and clinical data to determine which type of antidepressant might be optimal before people with depression start treatment.

Detailed description

The treatment of depression is often trial-and-error. Earlier research reported that only 50% of individuals with depression show a significant decline in symptoms after taking an antidepressant. The situation is even worse in primary care, where only 30% respond to first line antidepressants. The difficulty in treating depression is likely because treatment selection is not based on each person's characteristics. While some depressed individuals may benefit from selective serotonin reuptake inhibitors (SSRIs), others might benefit more from other types of medication. Finding markers that predict an individual's response to different antidepressants would provide patients and clinicians with valuable information to guide treatment selection. The present study is among the first to use clinical (e.g., responses on questionnaires), behavioral (e.g., performance in computerized tasks), and brain (e.g., MRI scans) data to guide treatment selection in order to increase the likelihood of benefiting from one of two antidepressants. After analyzing an individuals' markers, subjects will be randomly assigned to receive a full 8-week course of an SSRI or non-SSRI. Throughout the study, participants will complete 9 total sessions over the course of 9-10 weeks, including an electroencephalogram (EEG) recording, a functional magnetic resonance imaging (fMRI) scan, an electrocardiogram (EKG) exam, interviews with clinicians, and a full 8-week course of an antidepressant.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Sertraline	Subjects will receive 8 weeks of sertraline while monitored by the study physician
DRUG	Bupropion	Subjects will receive 8 weeks of bupropion while monitored by the study physician

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-08-26
• Completion: 2025-08-26
• First posted: 2022-09-13
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study