drugset / Trial / NCT02720198
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD
Phase 3
Completed
60 enrolled
Duke University
Forest Laboratories · collabInstitute for Advanced Medical Research, Alpharetta, GA · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study's primary objective is to compare the efficacy and tolerability of switching patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new treatment (quetiapine) to the participants' existing treatment with people diagnosed with depression (major depression disorder). The secondary objective is to examine the response and remission rates following the switch from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with examining changes in neurocognitive and apathy measures after the switch.
Timeline
- Start
- 2017-01-23
- Primary completion
- 2018-06-12
- Completion
- 2018-06-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levomilnacipran | Small molecule | 40 mg | — |
| Comparator | Levomilnacipran | Small molecule | 120 mg | — |
| Comparator | Quetiapine | Small molecule | 150 mg | — |
| Comparator | Quetiapine | Small molecule | 300 mg | — |