Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD
| Condition | Treatment Resistant Major Depressive Disorder |
|---|---|
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Status | Completed |
| Enrollment | 278 participants |
| Interventions | Aripiprazole, Repetitive transcranial magnetic stimulation (rTMS), Venlafaxine XR |
| Start date | Jul 13, 2017 |
| Completion date | Apr 24, 2022 |
| Results posted | Jul 9, 2026 |
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.
Montgomery-Asberg Depression Rating Scale (MADRS)
| Aripiprazole Augmentation | -14.9 ± 1.1 points |
|---|---|
| rTMS Augmentation | -17.39 ± 1.3 points |
| Switch to Venlafaxine XR/Duloxetine | -13.22 ± 1.1 points |
Open in BENITIONS View on ClinicalTrials.gov
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