NCT02977299

Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD

Augmentation Versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With Treatment Resistant Depression (ASCERTAIN-TRD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine.

Conditions

• Treatment Resistant Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Oral adjunctive therapy with aripiprazole, dose adjusted for effectiveness and tolerability.
DEVICE	Repetitive transcranial magnetic stimulation (rTMS)	Adjunctive therapy with transcranial magnetic stimulation, dose adjusted for effectiveness and tolerability.
DRUG	Venlafaxine XR	Oral switch therapy with venlafaxine, dose adjusted for effectiveness and tolerability.

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-04-24
• Completion: 2022-04-24
• First posted: 2016-11-30
• Last updated: 2022-04-27

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study
• FDA-regulated device study