Phase 3
Completed N=713
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Source: ClinicalTrials.gov NCT00969709 ↗Enrolled (actual)
713
Serious AEs
1.0%
Results posted
Oct 2013
Primary outcomePrimary: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -11.6; -14.8; -15.6; -16.5 Units on a scale — p=0.0186
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
-11.6; -14.8; -15.6; -16.5 | 0.0186 sig |
| SECONDARY Change in Sheehan Disability Scale (SDS) Total Score |
-7.2; -8.6; -9.7; -9.7 | 0.1687 |
Eligibility Criteria
Inclusion Criteria
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- The patient's current depressive episode must be at least 8 weeks in duration
Exclusion Criteria
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
- Patients with a history of meeting DSM-IV-TR criteria for:
- any manic or hypomanic episode
- schizophrenia or any other psychotic disorder
- obsessive-compulsive disorder
- Patients who are considered a suicide risk
Data sourced from ClinicalTrials.gov (NCT00969709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.