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NCT01288079 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
A Phase 2 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
NCT01288079: Clinical Trial Phase 2 study, sponsored by AstraZeneca.
NCT01288079 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 145 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01288079, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.
Primary Outcome
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Interventions
- DRUG Placebo
- DRUG Duloxetine
- DRUG TC-5214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
Why NCT01288079 stopped before completion
NCT01288079 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01288079 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01288079 about?
NCT01288079 is a clinical study titled "A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.". The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.
What is the current status of trial NCT01288079?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2011-02. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01288079?
The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG), TC-5214 (DRUG).
Who is sponsoring clinical trial NCT01288079?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01288079's enrollment target sits among peer trials
145 498th of 2000 higher than 1,501 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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