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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01254305
First received: December 3, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Major Depressive Disorder
Drug: Levomilnacipran ER
Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued

  • Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.


Secondary Outcome Measures:
  • Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
    The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems—with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).


Enrollment: 262
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40 -120 mg/day Levomilnacipran ER capsules, oral administration
Drug: Levomilnacipran ER
Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks
Active Comparator: 2
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing
Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks
Placebo Comparator: 3
Matching placebo capsules, oral administration
Drug: Placebo
Matching placebo capsules, oral administration, once daily dosing

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254305

Locations
United States, Alabama
Forest Investigative Site 010
Birmingham, Alabama, United States, 35216
United States, Arkansas
Forest Investigative Site 002
Little Rock, Arkansas, United States, 72223
United States, California
Forest Investigative Site 001
Cerritos, California, United States, 90703
United States, Florida
Forest Investigative Site 014
Fort Myers, Florida, United States, 33912
Forest Investigative Site 006
Jacksonville, Florida, United States, 32216
Forest Investigative Site 017
Orange City, Florida, United States, 32763
Forest Investigative Site 005
Orlando, Florida, United States, 32806
Forest Investigative Site 012
Tampa, Florida, United States, 33613
United States, Georgia
Forest Investigative Site 009
Atlanta, Georgia, United States, 30308
United States, Illinois
Forest Investigative Site 016
Joliet, Illinois, United States, 60435
United States, Louisiana
Forest Investigative Site 004
New Orleans, Louisiana, United States, 70122
United States, Massachusetts
Forest Investigative Site 022
Boston, Massachusetts, United States, 02135
United States, New York
Forest Investigative Site 011
Bronx, New York, United States, 10467
Forest Investigative Site 015
Cedarhurst, New York, United States, 11516
United States, Ohio
Forest Investigative Site 003
Cincinnati, Ohio, United States, 45227
Forest Investigative Site 013
Dayton, Ohio, United States, 45417
United States, Rhode Island
Forest Investigative Site 020
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Forest Investigative Site 018
Memphis, Tennessee, United States, 38119
United States, Texas
Forest Investigative Site 008
Dallas, Texas, United States, 75235
United States, Wisconsin
Forest Investigative Site 007
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carl Gommoll, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01254305     History of Changes
Other Study ID Numbers: LVM-MD-06
Study First Received: December 3, 2010
Results First Received: August 22, 2013
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Depression
Fatigue
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Fatigue
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Signs and Symptoms
Citalopram
Fluoxetine
Milnacipran
Paroxetine
Sertraline
Serotonin Uptake Inhibitors
Dexetimide
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents

ClinicalTrials.gov processed this record on August 25, 2014