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NCT01128452 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of EVT 101 in Treatment-Resistant Depression
A Phase 2 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01128452: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.
NCT01128452 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01128452, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.
Primary Outcome
AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires
Interventions
- DRUG Placebo
- DRUG EVT 101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
Why NCT01128452 stopped before completion
NCT01128452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01128452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01128452 about?
NCT01128452 is a clinical study titled "Safety and Efficacy of EVT 101 in Treatment-Resistant Depression". This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101...
What is the current status of trial NCT01128452?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2010-06. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01128452?
The interventions under investigation include: Placebo (DRUG), EVT 101 (DRUG).
Who is sponsoring clinical trial NCT01128452?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01128452's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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