Safety and Efficacy of F2695 SR in Adults With Fatigue Associated With Major Depressive Disorder

Condition(s) targeted: Major Depressive Disorder

Intervention: F2695 SR (Drug); Paroxetine, Sertraline, Citalopram or Fluoxetine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Carl Gommoll, MS, Study Director, Affiliation: Forest Laboratories

Overall contact:
Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

The purpose of the study is to evaluate the efficacy, safety and tolerability of F2695 sustained release (SR) for the treatment of fatigue associated with major depressive disorder (MDD).

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Clinical Global Impression of Severity (CGI-S) for Fatigue

Patient Global Impressions of Severity (PGI-S) for Fatigue

Secondary outcome: Cognitive and Physical Functioning Questionnaire (CPFQ)

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women, 18-65 years old

- Currently meet 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: a. any manic or hypomanic

episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.

- Patients who are considered a suicide risk

Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

Forest Investigative Site 010, Birmingham, Alabama 35216, United States; Recruiting

Forest Investigative Site 002, Little Rock, Arkansas 72223, United States; Recruiting

Forest Investigative Site 001, Cerritos, California 90703, United States; Recruiting

Forest Investigative Site 014, Fort Myers, Florida 33912, United States; Recruiting

Forest Investigative Site 006, Jacksonville, Florida 32216, United States; Active, not recruiting

Forest Investigative Site 017, Orange City, Florida 32763, United States; Recruiting

Forest Investigative Site 005, Orlando, Florida 32806, United States; Active, not recruiting

Forest Investigative Site 012, Tampa, Florida 33613, United States; Recruiting

Forest Investigative Site 009, Atlanta, Georgia 30308, United States; Active, not recruiting

Forest Investigative Site 016, Joliet, Illinois 60435, United States; Recruiting

Forest Investigative Site 004, New Orleans, Louisiana 70122, United States; Terminated

Forest Investigative Site 022, Boston, Massachusetts 02135, United States; Recruiting

Forest Investigative Site 011, Bronx, New York 10467, United States; Recruiting

Forest Investigative Site 015, Cedarhurst, New York 11516, United States; Recruiting

Forest Investigative Site 003, Cincinnati, Ohio 45227, United States; Recruiting

Forest Investigative Site 013, Dayton, Ohio 45417, United States; Recruiting

Forest Investigative Site 020, Lincoln, Rhode Island 02865, United States; Recruiting

Forest Investigative Site 018, Memphis, Tennessee 38119, United States; Active, not recruiting

Forest Investigative Site 008, Dallas, Texas 75235, United States; Recruiting

Forest Investigative Site 007, Middleton, Wisconsin 53562, United States; Recruiting

Starting date: April 2011
Last updated: August 16, 2011