Phase 3
Completed N=562
Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
Source: ClinicalTrials.gov NCT01377194 ↗Enrolled (actual)
562
Serious AEs
0.7%
Results posted
Oct 2013
Primary outcomePrimary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis. — -11.3; -14.6; -14.4 Units on a scale — p=0.0027
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis. |
-11.3; -14.6; -14.4 | 0.0027 sig |
| SECONDARY Change in Sheehan Disability Scale (SDS) Total Score |
-5.4; -7.3; -8.2 | 0.0459 sig |
Eligibility Criteria
Inclusion Criteria
- Men and women, 18-75 years old
- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- The patient's current depressive episode must be at least 6 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 who are considered a suicide risk
- Patients with a history of meeting DSM-IV-TR criteria for
- a. any manic or hypomanic episode
- b. schizophrenia or any other psychotic disorder
- c. obsessive-compulsive disorder.
Data sourced from ClinicalTrials.gov (NCT01377194). 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.