Overview

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forest Laboratories
Treatments:
Citalopram
Dexetimide
Fluoxetine
Levomilnacipran
Milnacipran
Paroxetine
Sertraline
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:

1. any manic or hypomanic episode;

2. schizophrenia or any other psychotic disorder;

3. obsessive-compulsive disorder.

- Patients who are considered a suicide risk