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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levomilnacipran ER
Paroxetine, Sertraline, Citalopram or Fluoxetine.
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Fatigue, Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 010
  • Forest Investigative Site 002
  • Forest Investigative Site 001
  • Forest Investigative Site 014
  • Forest Investigative Site 006
  • Forest Investigative Site 017
  • Forest Investigative Site 005
  • Forest Investigative Site 012
  • Forest Investigative Site 009
  • Forest Investigative Site 016
  • Forest Investigative Site 004
  • Forest Investigative Site 022
  • Forest Investigative Site 011
  • Forest Investigative Site 015
  • Forest Investigative Site 003
  • Forest Investigative Site 013
  • Forest Investigative Site 020
  • Forest Investigative Site 018
  • Forest Investigative Site 008
  • Forest Investigative Site 007

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

40 -120 mg/day Levomilnacipran ER capsules, oral administration

Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing

Matching placebo capsules, oral administration

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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).

Full Information

First Posted
December 3, 2010
Last Updated
August 5, 2014
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01254305
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Fatigue, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
40 -120 mg/day Levomilnacipran ER capsules, oral administration
Arm Title
2
Arm Type
Active Comparator
Arm Description
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules, oral administration
Intervention Type
Drug
Intervention Name(s)
Levomilnacipran ER
Intervention Description
Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Paroxetine, Sertraline, Citalopram or Fluoxetine.
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules, oral administration, once daily dosing
Primary Outcome Measure Information:
Title
Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
Description
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
Time Frame
From Baseline to Week 8
Title
Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
Description
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.
Time Frame
From Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward
Description
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).
Time Frame
From Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: any manic or hypomanic episode; schizophrenia or any other psychotic disorder; obsessive-compulsive disorder. Patients who are considered a suicide risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Gommoll, MS
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 010
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Forest Investigative Site 002
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
Forest Investigative Site 001
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Forest Investigative Site 014
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 006
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 017
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Forest Investigative Site 005
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 012
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 009
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Forest Investigative Site 016
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Forest Investigative Site 004
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
Forest Investigative Site 022
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Forest Investigative Site 011
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Investigative Site 015
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Forest Investigative Site 003
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Forest Investigative Site 013
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 020
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 018
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 008
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Forest Investigative Site 007
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

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

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