BENITIONSClinical Trial Intelligence

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

4상 완료 NCT02977299

대상 질환Treatment Resistant Major Depressive Disorder
임상 단계4상
스폰서Massachusetts General Hospital
상태완료
참여자 수278 명
중재(약물)Aripiprazole, Repetitive transcranial magnetic stimulation (rTMS), Venlafaxine XR
시작일2017년 7월 13일
완료일2022년 4월 24일
결과 공개일2026년 7월 9일

요약

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)

8 weeks · points

Aripiprazole Augmentation-14.9 ± 1.1 points
rTMS Augmentation-17.39 ± 1.3 points
Switch to Venlafaxine XR/Duloxetine-13.22 ± 1.1 points

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