NCT04748276

Tracking Response to Antidepressants in Advance of Investigational Trials

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Adams Clinical · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals meeting criteria for Major Depressive Disorder (MDD) and seeking enrollment in investigational trials.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)	Protocol-approved antidepressant treatments (ADT) will be prescribed in accordance with standard of care, whenever possible following dosing recommendations within the Study Formulary and Prescribing Guidelines (Sertraline 100 mg/day; Citalopram 20 mg/day; Escitalopram 10 mg/day; Fluoxetine 20 mg/day; Paroxetine 20 mg/day; Duloxetine 60 mg/day; Buproprion 300 mg/day; Desvenlafaxine 50 mg/day; Venlafaxine 150 mg/day). ADTs may be up or down-tapered as necessary.

Timeline

• Start date: 2019-01-02
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-02-10
• Last updated: 2023-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study