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NCT02977299 · ClinicalTrials.gov registry record · Phase 4
Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 278
- Enrollment target
NCT02977299: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT02977299 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 278 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02977299, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 278 participants
- Enrollment target
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.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale that assesses the severity of depressive symptoms. The scale consists of 10 items evaluating apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 to 6. Item scores are summed to calculate a total MADRS score ranging from 0 to 60, with higher scores indicatin
Interventions
- DEVICE Repetitive transcranial magnetic stimulation (rTMS)
- DRUG Aripiprazole
- DRUG Venlafaxine XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2017-07-13 |
| Est. Completion | 2022-04-24 |
| Phase | Phase 4 |
What the finished NCT02977299 record still lists
NCT02977299 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 3 interventions - of which Repetitive transcranial magnetic stimulation (rTMS) is the first listed.
NCT02977299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02977299 about?
NCT02977299 is a clinical study titled "Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD". 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 su...
What is the current status of trial NCT02977299?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 278 participants. The study started on 2017-07-13. Estimated completion is 2022-04-24.
What interventions are being tested in trial NCT02977299?
The interventions under investigation include: Repetitive transcranial magnetic stimulation (rTMS) (DEVICE), Aripiprazole (DRUG), Venlafaxine XR (DRUG).
Who is sponsoring clinical trial NCT02977299?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02977299's enrollment target sits among peer trials
278 307th of 2000 higher than 1,691 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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