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Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levomilnacipran ER
Levomilnacipran ER
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, Major Depressive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women, 18-75 years old
  • Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
  • The patient's current depressive episode must be at least 6 weeks in duration

Exclusion Criteria:

  • Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
  • Patients who are considered a suicide risk
  • 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.

Sites / Locations

  • Forest Investigative Site 039
  • Forest Investigative Site 037
  • Forest Investigative Site 012
  • Forest Investigative Site 038
  • Forest Investigative Site 024
  • Forest Investigative Site 001
  • Forest Investigative Site 031
  • Forest Investigative Site 050
  • Forest Investigative Site 034
  • Forest Investigative Site 021
  • Forest Investigative Site 043
  • Forest Investigative Site 018
  • Forest Investigative Site 060
  • Forest Investigative Site 020
  • Forest Investigative Site 005
  • Forest Investigative Site 014
  • Forest Investigative Site 028
  • Forest Investigative Site 046
  • Forest Investigative Site 041
  • Forest Investigative Site 054
  • Forest Investigative Site 026
  • Forest Investigative Site 045
  • Forest Investigative Site 056
  • Forest Investigative Site 049
  • Forest Investigative Site 044
  • Forest Investigative Site 023
  • Forest Investigative Site 004
  • Forest Investigative Site 002
  • Forest Investigative Site 016
  • Forest Investigative Site 051
  • Forest Investigative Site 042
  • Forest Investigative Site 061
  • Forest Investigative Site 010
  • Forest Investigative Site 048
  • Forest Investigative Site 053
  • Forest Investigative Site 017
  • Forest Investigative Site 011
  • Forest Investigative Site 052
  • Forest Investigative Site 027
  • Forest Investigative Site 059
  • Forest Investigative Site 029
  • Forest Investigative Site 009
  • Forest Investigative Site 007
  • Forest Investigative Site 035
  • Forest Investigative Site 022
  • Forest Investigative Site 055
  • Forest Investigative Site 057
  • Forest Investigative Site 025
  • Forest Investigative Site 036
  • Forest Investigative Site 006
  • Forest Investigative Site 003

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

40mg Levomilnacipran ER

80mg of Levomilnacipran ER

Placebo

Outcomes

Primary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.
The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).

Secondary Outcome Measures

Change in Sheehan Disability Scale (SDS) Total Score
The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)

Full Information

First Posted
June 10, 2011
Last Updated
August 22, 2013
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01377194
Brief Title
Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
Official Title
A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 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 this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients 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, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
40mg Levomilnacipran ER
Arm Title
2
Arm Type
Experimental
Arm Description
80mg of Levomilnacipran ER
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Levomilnacipran ER
Intervention Description
Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Levomilnacipran ER
Intervention Description
Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Primary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.
Description
The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).
Time Frame
From Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change in Sheehan Disability Scale (SDS) Total Score
Description
The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)
Time Frame
From Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, 18-75 years old Currently meet the DSM-IV-TR criteria for Major Depressive Disorder The patient's current depressive episode must be at least 6 weeks in duration Exclusion Criteria: Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control. Patients who are considered a suicide risk 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Gommoll, MS
Organizational Affiliation
Forest Research Institute, a subsidiary of Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 039
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Forest Investigative Site 037
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 012
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Forest Investigative Site 038
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Forest Investigative Site 024
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 001
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Forest Investigative Site 031
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site 050
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 034
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Forest Investigative Site 021
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Forest Investigative Site 043
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 018
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 060
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Forest Investigative Site 020
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 005
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Forest Investigative Site 014
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 028
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 046
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 041
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Forest Investigative Site 054
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Forest Investigative Site 026
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 045
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 056
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Forest Investigative Site 049
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Forest Investigative Site 044
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 023
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Forest Investigative Site 004
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 002
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Forest Investigative Site 016
City
New York City
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 051
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 042
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
Forest Investigative Site 061
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Forest Investigative Site 010
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 048
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 053
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 017
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Forest Investigative Site 011
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Forest Investigative Site 052
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Facility Name
Forest Investigative Site 027
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Forest Investigative Site 059
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 029
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 009
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 007
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 035
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 022
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 055
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site 057
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Forest Investigative Site 025
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Forest Investigative Site 036
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1S 2EB
Country
Canada
Facility Name
Forest Investigative Site 006
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 1B7
Country
Canada
Facility Name
Forest Investigative Site 003
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26644957
Citation
Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
Results Reference
derived
PubMed Identifier
24144196
Citation
Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

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