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NCT01152554 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 813
- Enrollment target
NCT01152554: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01152554 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 813 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01152554, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 813 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 for 52 weeks with another antidepressant medicine.
Primary Outcome
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
Interventions
- DRUG Placebo
- DRUG TC-5214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT01152554 record still lists
NCT01152554 is an interventional study that assigns participants to a tested intervention. The registered 813 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01152554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01152554 about?
NCT01152554 is a clinical study titled "A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder". 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 for 52 weeks with another antidepressant medicine.
What is the current status of trial NCT01152554?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 813 participants. The study started on 2010-06. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01152554?
The interventions under investigation include: Placebo (DRUG), TC-5214 (DRUG).
Who is sponsoring clinical trial NCT01152554?
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 NCT01152554's enrollment target sits among peer trials
813 407th of 2000 higher than 1,593 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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