A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Summary
The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12 milligrams \[mg\] or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.
Timeline
- Start
- 2010-11
- Primary completion
- 2013-10
- Completion
- 2013-10
Outcome
Missed primary endpoint
registry analysis (superiority or other test); 12 mg LY2216684 + SSRI vs Placebo + SSRI; p = 0.338 NCT01173601 ↗
registry analysis (superiority or other test); 18 mg LY2216684 + SSRI vs Placebo + SSRI; p = 0.201 NCT01173601 ↗
paper Each trial failed to meet the primary and most of the secondary objectives. PMID 27035159 ↗
Publications
- Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.
- Ball SG, Ferguson MB, Martinez JM, Pangallo BA, Nery ES, Dellva MA, Sparks J, Zhang Q, Liu P, Bangs M, Goldberger C. Efficacy outcomes from 3 clinical trials of edivoxetine as adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment. J Clin Psychiatry. 2016 May;77(5):635-42. doi: 10.4088/JCP.14m09619.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | edivoxetine | Small molecule | 12 mg | Oral |
| Subject | edivoxetine | Small molecule | 18 mg | Oral |