drugset / Trial / NCT01288079
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2011-02
- Primary completion
- 2012-08
- Completion
- 2012-08
Outcome
Missed primary endpoint
registry analysis (superiority or other test); 1 mg BID TC-5214 vs Placebo; p = 0.617; LS mean -1.5 (95% CI -7.35 to 4.39); MMRM NCT01288079 ↗
registry analysis (superiority or other test); 4 mg BID TC-5214 vs Placebo; p = 0.277; LS mean -3.6 (95% CI -10.06 to 2.91); MMRM NCT01288079 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Duloxetine | Small molecule | 60 mg | Oral |
| Subject | dexmecamylamine | Other / unclassified | 1 mg | Oral |
| Subject | dexmecamylamine | Other / unclassified | 4 mg | Oral |