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

NCT02977299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2022-04-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2022-04-24
Completion
2022-04-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02977299 on ClinicalTrials.gov