Clinical trial NCT01254305: Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Official title: A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
Fatigue
Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

  1. any manic or hypomanic episode;
  2. schizophrenia or any other psychotic disorder;
  3. obsessive-compulsive disorder.
* Patients who are considered a suicide risk

Primary outcomes:
measure: Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
timeFrame: From Baseline to Week 8
measure: Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
timeFrame: From Baseline to Week 8
Secondary outcomes:
measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward
timeFrame: From Baseline to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 010
state: Alabama
city: Little Rock
country: United States
facility: Forest Investigative Site 002
state: Arkansas
city: Cerritos
country: United States
facility: Forest Investigative Site 001
state: California
city: Fort Myers
country: United States
facility: Forest Investigative Site 014
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 006
state: Florida
city: Orange City
country: United States
facility: Forest Investigative Site 017
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 005
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 009
state: Georgia
city: Joliet
country: United States
facility: Forest Investigative Site 016
state: Illinois
city: New Orleans
country: United States
facility: Forest Investigative Site 004
state: Louisiana
city: Boston
country: United States
facility: Forest Investigative Site 022
state: Massachusetts
city: Bronx
country: United States
facility: Forest Investigative Site 011
state: New York
city: Cedarhurst
country: United States
facility: Forest Investigative Site 015
state: New York
city: Cincinnati
country: United States
facility: Forest Investigative Site 003
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 013
state: Ohio
city: Lincoln
country: United States
facility: Forest Investigative Site 020
state: Rhode Island
city: Memphis
country: United States
facility: Forest Investigative Site 018
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 008
state: Texas
city: Middleton
country: United States
facility: Forest Investigative Site 007
state: Wisconsin
Study officials:
affiliation: Forest Laboratories
name: Carl Gommoll, MS
role: STUDY_DIRECTOR
References: