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NCT01670019 · ClinicalTrials.gov registry record · Phase 4
Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT01670019: Completed Phase 4 study, sponsored by Duke University.
NCT01670019 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 46 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01670019, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone. The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.
Primary Outcome
The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Interventions
- DRUG Asenapine 5-20 mg daily
- DRUG Placebo 1-4 tablets daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01670019 record still lists
NCT01670019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Asenapine 5-20 mg daily is the first listed.
NCT01670019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01670019 about?
NCT01670019 is a clinical study titled "Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression". This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone. The investigators hypothesize that added asenapine will produce gre...
What is the current status of trial NCT01670019?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2012-10. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01670019?
The interventions under investigation include: Asenapine 5-20 mg daily (DRUG), Placebo 1-4 tablets daily (DRUG).
Who is sponsoring clinical trial NCT01670019?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01670019's enrollment target sits among peer trials
46 1348th of 2000 higher than 647 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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