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NCT01157078 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 319
- Enrollment target
NCT01157078: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01157078 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01157078, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.
Primary Outcome
A 10-item scale for the evaluation of depressive symptoms. Each 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 TC-5214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01157078 record still lists
NCT01157078 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01157078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01157078 about?
NCT01157078 is a clinical study titled "A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)". The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.
What is the current status of trial NCT01157078?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2010-06. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01157078?
The interventions under investigation include: Placebo (DRUG), TC-5214 (DRUG).
Who is sponsoring clinical trial NCT01157078?
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 NCT01157078's enrollment target sits among peer trials
319 1087th of 2000 higher than 914 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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