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

Major Depressive Disorder Clinical Trial

Official title:

A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254305
• Other study ID #: LVM-MD-06
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: August 5, 2014
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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
• 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
Matching placebo capsules, oral administration, once daily dosing

Locations

Country	Name	City	State
United States	Forest Investigative Site 009	Atlanta	Georgia
United States	Forest Investigative Site 010	Birmingham	Alabama
United States	Forest Investigative Site 022	Boston	Massachusetts
United States	Forest Investigative Site 011	Bronx	New York
United States	Forest Investigative Site 015	Cedarhurst	New York
United States	Forest Investigative Site 001	Cerritos	California
United States	Forest Investigative Site 003	Cincinnati	Ohio
United States	Forest Investigative Site 008	Dallas	Texas
United States	Forest Investigative Site 013	Dayton	Ohio
United States	Forest Investigative Site 014	Fort Myers	Florida
United States	Forest Investigative Site 006	Jacksonville	Florida
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 018	Memphis	Tennessee
United States	Forest Investigative Site 007	Middleton	Wisconsin
United States	Forest Investigative Site 004	New Orleans	Louisiana
United States	Forest Investigative Site 017	Orange City	Florida
United States	Forest Investigative Site 005	Orlando	Florida
United States	Forest Investigative Site 012	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score	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	From Baseline to Week 8	No
Primary	Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score	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.	From Baseline to Week 8	No
Secondary	Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward	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).	From Baseline to Week 8	No