Trials / Completed
CompletedNCT01152554
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 813 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TC-5214 | Tablet, oral, twice daily for 52 weeks |
| DRUG | Placebo | Tablet, oral, twice daily for 52 weeks |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2012-02-01
- Completion
- 2012-02-01
- First posted
- 2010-06-29
- Last updated
- 2014-04-11
- Results posted
- 2012-10-29
Locations
94 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01152554. Inclusion in this directory is not an endorsement.