Phase 2
N=262
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01254305 ↗Enrolled (actual)
262
Serious AEs
0.4%
Results posted
Aug 2014
Primary outcome: Primary: Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score — -1.5; -1.8; -1.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Levomilnacipran ER (Drug); Paroxetine, Sertraline, Citalopram or Fluoxetine. (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score |
-1.5; -1.8; -1.9 | — |
| PRIMARY Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score |
-1.4; -1.7; -1.7 | — |
| SECONDARY Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward |
-5.9; -7.0; -6.4 | — |
Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).
Eligibility Criteria
Inclusion Criteria
- Men and women, 18-65 years old
- Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder
- The patient's current depressive episode must be at least 4 weeks in duration
Exclusion Criteria
- Women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing 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 (NCT01254305). 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.