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

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.

Timeline

Start

2017-07-13

Primary completion

2022-04-24

Completion

2022-04-24

Outcome

Met primary endpoint

paper Repetitive transcranial magnetic stimulation augmentation was shown to be more effective than switching antidepressants in treatment-resistant depression on the study primary measure. PMID 38454079 ↗

Publications

• Guidetti C, Chaikali S, Trivedi MH, Shelton RC, Iosifescu DV, Thase ME, Jha MK, Mathew SH, DeBattista C, Dokucu ME, Brawman-Mintzer O, Hernandez Ortiz JM, Currier GW, McCall WV, Modirrousta M, Macaluso M, Bystritsky A, Vila-Rodriguez F, Nelson EB, Yeung AS, MacGregor LC, Carmody T, Fava M, Papakostas GI. Comparative Effectiveness Research Trial for Antidepressant Incomplete and Nonresponders With Treatment Resistant Depression (ASCERTAIN-TRD): Effect of Aripiprazole or Repetitive Transcranial Magnetic Stimulation Augmentation Versus Switching to the Antidepressant Venlafaxine on Quality of Life. J Clin Psychiatry. 2025 Aug 11;86(3):24m15614. doi: 10.4088/JCP.24m15614.
• Papakostas GI, Trivedi MH, Shelton RC, Iosifescu DV, Thase ME, Jha MK, Mathew SJ, DeBattista C, Dokucu ME, Brawman-Mintzer O, Currier GW, McCall WV, Modirrousta M, Macaluso M, Bystritsky A, Rodriguez FV, Nelson EB, Yeung AS, Feeney A, MacGregor LC, Carmody T, Fava M. Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial. Mol Psychiatry. 2024 Aug;29(8):2287-2295. doi: 10.1038/s41380-024-02468-x. Epub 2024 Mar 7.

Drugs

Indications