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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Levomilnacipran ER; Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.; Drug: Placebo

• Registration Number: NCT01254305
• Lead Sponsor: Forest Laboratories

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Study Start: 2011-04
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Disposition First Submitted: 2012-07-25
• Disposition First Submitted QC: 2012-07-25
• Disposition First Posted: 2012-08-02
• Results First Submitted: 2013-08-22
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Results First Posted: 2014-08-06
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Levomilnacipran ER	40 -120 mg/day Levomilnacipran ER capsules, oral administration
2	Paroxetine, Sertraline, Citalopram or Fluoxetine.	Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing
3	Placebo	Matching placebo capsules, oral administration

Primary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score	From Baseline to Week 8	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	From Baseline to Week 8	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

Name	Time	Method
Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward	From Baseline to Week 8	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).

Trial Locations

Locations (20)

Forest Investigative Site 022; 🇺🇸 Boston, Massachusetts, United States

Forest Investigative Site 006; 🇺🇸 Jacksonville, Florida, United States

Forest Investigative Site 013; 🇺🇸 Dayton, Ohio, United States

Forest Investigative Site 001; 🇺🇸 Cerritos, California, United States

Forest Investigative Site 005; 🇺🇸 Orlando, Florida, United States

Forest Investigative Site 010; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 014; 🇺🇸 Fort Myers, Florida, United States

Forest Investigative Site 012; 🇺🇸 Tampa, Florida, United States

Forest Investigative Site 017; 🇺🇸 Orange City, Florida, United States

Forest Investigative Site 015; 🇺🇸 Cedarhurst, New York, United States

Forest Investigative Site 009; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site 007; 🇺🇸 Middleton, Wisconsin, United States

Forest Investigative Site 004; 🇺🇸 New Orleans, Louisiana, United States

Forest Investigative Site 018; 🇺🇸 Memphis, Tennessee, United States

Forest Investigative Site 008; 🇺🇸 Dallas, Texas, United States

Forest Investigative Site 016; 🇺🇸 Joliet, Illinois, United States

Forest Investigative Site 020; 🇺🇸 Lincoln, Rhode Island, United States

Forest Investigative Site 002; 🇺🇸 Little Rock, Arkansas, United States

Forest Investigative Site 011; 🇺🇸 Bronx, New York, United States

Forest Investigative Site 003; 🇺🇸 Cincinnati, Ohio, United States