At a glance
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Augmentation Versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With Treatment Resistant Depression (ASCERTAIN-TRD)
In Brief
A Phase 4 clinical trial evaluating Aripiprazole, Repetitive transcranial magnetic stimulation (rTMS), and 1 other intervention for Treatment Resistant Major Depressive Disorder. Completed, enrolled 278 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Oral adjunctive therapy with aripiprazole, dose adjusted for effectiveness and tolerability.
Adjunctive therapy with transcranial magnetic stimulation, dose adjusted for effectiveness and tolerability.
Oral switch therapy with venlafaxine, dose adjusted for effectiveness and tolerability.